{"fetched":"2026-09-16","previousFetched":"2026-09-09","window":{"from":"2026-05-19","to":"2026-09-16"},"sources":{"oce":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","drugsfda":"https://api.fda.gov/drug/drugsfda.json"},"oce":[{"date":"2026-09-09","title":"FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small","summary":"On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.","drugIds":["sevabertinib"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-09-04","title":"FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative","summary":"On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.","drugIds":["camizestrant","palbociclib","abemaciclib","ribociclib"],"cancerIds":["breast-hr-positive"],"firstSeen":"2026-09-09"},{"date":"2026-08-26","title":"FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma","summary":"On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.","drugIds":["daraxonrasib"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-08-25","title":"FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction","summary":"On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.: dolutegravir","drugIds":["tislelizumab","zanidatamab","platinum-etoposide"],"cancerIds":["gastric"],"firstSeen":"2026-09-09"},{"date":"2026-08-13","title":"FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone","summary":"On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.","drugIds":["dexamethasone","daratumumab","iberdomide"],"cancerIds":["multiple-myeloma"],"firstSeen":"2026-09-09"},{"date":"2026-08-06","title":"FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma","summary":"On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.","drugIds":["vusolimogene-oderparepvec","nivolumab","relatlimab-nivolumab"],"cancerIds":["melanoma"],"firstSeen":"2026-09-09"},{"date":"2026-07-31","title":"FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy","summary":"On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).","drugIds":["pluvicto"],"cancerIds":["prostate"],"firstSeen":"2026-09-09"},{"date":"2026-07-22","title":"FDA approves zidesamtinib for ROS1 -positive non-small cell lung cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer","summary":"On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).","drugIds":["zidesamtinib"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-07-14","title":"FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally","summary":"On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.","drugIds":["fulvestrant","palbociclib","gedatolisib"],"cancerIds":["breast-hr-positive"],"firstSeen":"2026-09-09"},{"date":"2026-07-14","title":"FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive","summary":"On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.","drugIds":["selpercatinib"],"cancerIds":[],"firstSeen":"2026-09-09"},{"date":"2026-07-10","title":"FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin","summary":"On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.","drugIds":["enfortumab-vedotin","pembrolizumab","gemcitabine-cisplatin","cisplatin"],"cancerIds":["urothelial"],"firstSeen":"2026-09-09"},{"date":"2026-07-09","title":"FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications","summary":"On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.","drugIds":["isatuximab"],"cancerIds":["multiple-myeloma"],"firstSeen":"2026-09-09"},{"date":"2026-06-24","title":"FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line","summary":"On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC).","drugIds":["sacituzumab-govitecan","pembrolizumab"],"cancerIds":["tnbc"],"firstSeen":"2026-09-09"},{"date":"2026-06-24","title":"FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance","summary":"On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.","drugIds":["palbociclib","trastuzumab","pertuzumab"],"cancerIds":["breast-hr-positive"],"firstSeen":"2026-09-09"},{"date":"2026-06-12","title":"FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation","summary":"On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.","drugIds":["capivasertib","prednisone"],"cancerIds":["prostate"],"firstSeen":"2026-09-09"},{"date":"2026-06-12","title":"FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma","summary":"On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.","drugIds":["pembrolizumab","belzutifan"],"cancerIds":["rcc"],"firstSeen":"2026-09-09"},{"date":"2026-05-28","title":"FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder","summary":"On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).","drugIds":["durvalumab"],"cancerIds":["urothelial"],"firstSeen":"2026-09-09"},{"date":"2026-05-27","title":"FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare","summary":"On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).","drugIds":["pivekimab-sunirine"],"cancerIds":["bpdcn"],"firstSeen":"2026-09-09"},{"date":"2026-05-22","title":"FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer","summary":"On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.","drugIds":["datopotamab-deruxtecan"],"cancerIds":["tnbc"],"firstSeen":"2026-09-09"}],"drugsfda":[{"applicationNumber":"NDA208081","sponsor":"BIOFRONTERA","brand":"AMELUZ","generic":"AMINOLEVULINIC ACID HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"40","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-09","drugIds":["aminolevulinic-acid"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA219972","sponsor":"BAYER HEALTHCARE","brand":"HYRNUO","generic":"SEVABERTINIB","submissionType":"SUPPL","submissionNumber":"1","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-09-09","drugIds":["sevabertinib"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA211182","sponsor":"HETERO LABS LTD V","brand":"IBRUTINIB","generic":"IBRUTINIB","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-09-08","drugIds":["ibrutinib"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA220359","sponsor":"ASTRAZENECA PHARMACEUTICALS, LP","brand":"ETCAMAH","generic":"CAMIZESTRANT","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-09-04","drugIds":["camizestrant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA213267","sponsor":"NATCO","brand":"THALIDOMIDE","generic":"THALIDOMIDE","submissionType":"SUPPL","submissionNumber":"2","classCode":"REMS","classDescription":"REMS","statusDate":"2026-09-02","drugIds":["thalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA213312","sponsor":"AADI","brand":"FYARRO","generic":"SIROLIMUS","submissionType":"SUPPL","submissionNumber":"14","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-02","drugIds":["sirolimus-albumin-bound"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761498","sponsor":"CELLTRION INC","brand":"AVTOZMA","generic":"TOCILIZUMAB","submissionType":"SUPPL","submissionNumber":"1","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-02","drugIds":["tocilizumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA020457","sponsor":"CHEPLAPHARM","brand":"ETOPOPHOS PRESERVATIVE FREE","generic":"ETOPOSIDE PHOSPHATE","submissionType":"SUPPL","submissionNumber":"20","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-02","drugIds":["platinum-etoposide","etoposide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761420","sponsor":"CELLTRION INC","brand":"AVTOZMA","generic":"TOCILIZUMAB","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-02","drugIds":["tocilizumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA020785","sponsor":"BRISTOL-MYERS","brand":"THALOMID","generic":"THALIDOMIDE","submissionType":"SUPPL","submissionNumber":"74","classCode":"REMS","classDescription":"REMS","statusDate":"2026-09-02","drugIds":["thalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA216340","sponsor":"BRISTOL","brand":"KRAZATI","generic":"ADAGRASIB","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-01","drugIds":["adagrasib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA216038","sponsor":"MEITHEAL","brand":"NELARABINE","generic":"NELARABINE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-09-01","drugIds":["nelarabine"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA220741","sponsor":"SANDOZ","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761049","sponsor":"EMD SERONO INC","brand":"BAVENCIO","generic":"AVELUMAB","submissionType":"SUPPL","submissionNumber":"26","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["avelumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210232","sponsor":"SPIL","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761069","sponsor":"ASTRAZENECA UK LTD","brand":"IMFINZI","generic":"DURVALUMAB","submissionType":"SUPPL","submissionNumber":"60","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["durvalumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA079086","sponsor":"PETNET","brand":"FLUDEOXYGLUCOSE F18","generic":"FLUDEOXYGLUCOSE F 18","submissionType":"SUPPL","submissionNumber":"31","classCode":"MANUF (CMC)","classDescription":"Manufacturing (CMC)","statusDate":"2026-08-31","drugIds":["fludeoxyglucose-f18"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761097","sponsor":"REGENERON PHARMACEUTICALS","brand":"LIBTAYO","generic":"CEMIPLIMAB-RWLC","submissionType":"SUPPL","submissionNumber":"38","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["cemiplimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125377","sponsor":"BRISTOL MYERS SQUIBB","brand":"YERVOY","generic":"IPILIMUMAB","submissionType":"SUPPL","submissionNumber":"140","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["ipilimumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761240","sponsor":"COHERUS BIOSCIENCES INC","brand":"LOQTORZI","generic":"TORIPALIMAB-TPZI","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["toripalimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761258","sponsor":"AKESO BIOPHARMA","brand":"PENPULIMAB-KCQX","generic":"PENPULIMAB","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["penpulimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219718","sponsor":"CIPLA","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761289","sponsor":"ASTRAZENECA AB","brand":"IMJUDO","generic":"TREMELIMUMAB","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["tremelimumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761297","sponsor":"CHECKPOINT THERAPEUTICS INC","brand":"UNLOXCYT","generic":"COSIBELIMAB","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-31","drugIds":["cosibelimab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213234","sponsor":"DR REDDYS","brand":"POMALIDOMIDE","generic":"POMALIDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-31","drugIds":["pomalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761166","sponsor":"PHARMAESSENTIA CORP","brand":"BESREMI","generic":"ROPEGINTERFERON ALFA-2B","submissionType":"SUPPL","submissionNumber":"13","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-08-28","drugIds":["ropeginterferon-alfa-2b"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA220605","sponsor":"TAKEDA PHARMS AM","brand":"MIMRYLO","generic":"RUSFERTIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-08-28","drugIds":["rusfertide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA220910","sponsor":"REVOLUTION MEDICINES","brand":"RASONQUE","generic":"DARAXONRASIB","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-08-26","drugIds":["daraxonrasib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA213225","sponsor":"SUN PHARM","brand":"VOBRIG","generic":"LEUPROLIDE ACETATE","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 5","classDescription":"Type 5 - New Formulation or New Manufacturer","statusDate":"2026-08-26","drugIds":["goserelin"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761416","sponsor":"JAZZ PHARMS","brand":"ZIIHERA","generic":"ZANIDATAMAB-HRII","submissionType":"SUPPL","submissionNumber":"2","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-08-25","drugIds":["zanidatamab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761416","sponsor":"JAZZ PHARMS","brand":"ZIIHERA","generic":"ZANIDATAMAB-HRII","submissionType":"SUPPL","submissionNumber":"3","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-25","drugIds":["zanidatamab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761232","sponsor":"BEIGENE","brand":"TEVIMBRA","generic":"TISLELIZUMAB-JSGR","submissionType":"SUPPL","submissionNumber":"18","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-08-25","drugIds":["tislelizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA206192","sponsor":"GENENTECH INC","brand":"COTELLIC","generic":"COBIMETINIB","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-20","drugIds":["cobimetinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA202429","sponsor":"HOFFMANN LA ROCHE","brand":"ZELBORAF","generic":"VEMURAFENIB","submissionType":"SUPPL","submissionNumber":"23","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-20","drugIds":["vemurafenib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA217677","sponsor":"SPRINGWORKS","brand":"OGSIVEO","generic":"NIROGACESTAT","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-20","drugIds":["nirogacestat"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761274","sponsor":"BIOCON BIOLOGICS INC","brand":"YESAFILI","generic":"AFLIBERCEPT-JBVF","submissionType":"SUPPL","submissionNumber":"8","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-20","drugIds":["ziv-aflibercept"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA220118","sponsor":"BIOCON PHARMA","brand":"NINTEDANIB ESYLATE","generic":"NINTEDANIB ESYLATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-19","drugIds":["nintedanib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213106","sponsor":"QILU PHARM HAINAN","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT DIMEGLUMINE","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-19","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA208434","sponsor":"HOFFMANN-LA ROCHE","brand":"ALECENSA","generic":"ALECTINIB HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"17","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-14","drugIds":["alectinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213878","sponsor":"MSN","brand":"CABOZANTINIB S-MALATE","generic":"CABOZANTINIB S-MALATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-14","drugIds":["cabozantinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA221075","sponsor":"BRISTOL MYERS SQUIBB","brand":"ZENBEXUS","generic":"IBERDOMIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-08-13","drugIds":["iberdomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125554","sponsor":"BRISTOL MYERS SQUIBB","brand":"OPDIVO","generic":"NIVOLUMAB","submissionType":"SUPPL","submissionNumber":"138","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-12","drugIds":["nivolumab","relatlimab-nivolumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA201848","sponsor":"DELCATH SYSTEMS INC","brand":"HEPZATO","generic":"MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","submissionType":"SUPPL","submissionNumber":"18","classCode":"REMS","classDescription":"REMS","statusDate":"2026-08-12","drugIds":["hepzato","melphalan"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA040266","sponsor":"FRESENIUS KABI USA","brand":"METHOTREXATE PRESERVATIVE FREE","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"23","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-11","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA206197","sponsor":"FRESENIUS KABI USA","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-07","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA212309","sponsor":"BE PHARMS","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT","submissionType":"SUPPL","submissionNumber":"18","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-07","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA210625","sponsor":"EUGIA PHARMA","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT DIMEGLUMINE","submissionType":"SUPPL","submissionNumber":"8","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-07","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA209965","sponsor":"MSN","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-07","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA209965","sponsor":"MSN","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-07","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA204015","sponsor":"MYLAN LABS LTD","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-07","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA219881","sponsor":"QILU PHARM HAINAN","brand":"DOXORUBICIN HYDROCHLORIDE","generic":"DOXORUBICIN HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"1","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-04","drugIds":["doxorubicin"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA212299","sponsor":"ZYDUS LIFESCIENCES","brand":"DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)","generic":"DOXORUBICIN HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"17","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-04","drugIds":["doxorubicin"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125031","sponsor":"AMGEN","brand":"NEULASTA","generic":"PEGFILGRASTIM","submissionType":"SUPPL","submissionNumber":"210","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-04","drugIds":["pegfilgrastim"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA203263","sponsor":"SUN PHARM","brand":"DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)","generic":"DOXORUBICIN HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"47","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-04","drugIds":["doxorubicin"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219199","sponsor":"ALEMBIC","brand":"DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)","generic":"DOXORUBICIN HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-04","drugIds":["doxorubicin"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA072945","sponsor":"HOSPIRA","brand":"CYTARABINE","generic":"CYTARABINE","submissionType":"SUPPL","submissionNumber":"31","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-03","drugIds":["cytarabine-7-3","cytarabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219926","sponsor":"MACLEODS PHARMS","brand":"NINTEDANIB ESYLATE","generic":"NINTEDANIB ESYLATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-08-03","drugIds":["nintedanib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA075383","sponsor":"HOSPIRA","brand":"CYTARABINE","generic":"CYTARABINE","submissionType":"SUPPL","submissionNumber":"24","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-03","drugIds":["cytarabine-7-3","cytarabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA072168","sponsor":"HOSPIRA","brand":"CYTARABINE","generic":"CYTARABINE","submissionType":"SUPPL","submissionNumber":"36","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-08-03","drugIds":["cytarabine-7-3","cytarabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761376","sponsor":"DR REDDYS LABS SA","brand":"ZIMRIXBY","generic":"RITUXIMAB-CDXX","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-31","drugIds":["rituximab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761400","sponsor":"RENGENERON PHARMACEUTICALS, INC.","brand":"LYNOZYFIC","generic":"LINVOSELTAMAB-GCPT","submissionType":"SUPPL","submissionNumber":"3","classCode":"REMS","classDescription":"REMS","statusDate":"2026-07-31","drugIds":["linvoseltamab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761467","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA QLEX","generic":"PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH","submissionType":"SUPPL","submissionNumber":"15","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-31","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA215833","sponsor":"NOVARTIS","brand":"PLUVICTO","generic":"LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN","submissionType":"SUPPL","submissionNumber":"37","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-31","drugIds":["pluvicto"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA219042","sponsor":"BOEHRINGER INGELHEIM","brand":"HERNEXEOS","generic":"ZONGERTINIB","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-31","drugIds":["zongertinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA219042","sponsor":"BOEHRINGER INGELHEIM","brand":"HERNEXEOS","generic":"ZONGERTINIB","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-31","drugIds":["zongertinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA071868","sponsor":"HOSPIRA","brand":"CYTARABINE","generic":"CYTARABINE","submissionType":"SUPPL","submissionNumber":"38","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-29","drugIds":["cytarabine-7-3","cytarabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA076972","sponsor":"FRESENIUS KABI USA","brand":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","generic":"ONDANSETRON HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"19","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-29","drugIds":["ondansetron"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA076974","sponsor":"FRESENIUS KABI USA","brand":"ONDANSETRON HYDROCHLORIDE","generic":"ONDANSETRON HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"18","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-29","drugIds":["ondansetron"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA217379","sponsor":"CYCLE","brand":"CAVHANZA","generic":"NILOTINIB","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-29","drugIds":["nilotinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA203939","sponsor":"CAPLIN","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT DIMEGLUMINE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-28","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA203415","sponsor":"ASTELLAS","brand":"XTANDI","generic":"ENZALUTAMIDE","submissionType":"SUPPL","submissionNumber":"26","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-24","drugIds":["enzalutamide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA213674","sponsor":"ASTELLAS","brand":"XTANDI","generic":"ENZALUTAMIDE","submissionType":"SUPPL","submissionNumber":"16","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-24","drugIds":["enzalutamide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761320","sponsor":"OUTLOOK THERAPEUTICS, INC.","brand":"LYTENAVA","generic":"BEVACIZUMAB-VIKG","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1/4","classDescription":"Type 1 - New Molecular Entity and Type 4 - New Combination","statusDate":"2026-07-24","drugIds":["bevacizumab-glioma","bevacizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA220196","sponsor":"HISUN PHARM HANGZHOU","brand":"FLUDARABINE PHOSPHATE","generic":"FLUDARABINE PHOSPHATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-23","drugIds":["fludarabine"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA220185","sponsor":"NUVALENT","brand":"JIDEYTRO","generic":"ZIDESAMTINIB","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-07-22","drugIds":["zidesamtinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA021880","sponsor":"BRISTOL MYERS SQUIBB","brand":"REVLIMID","generic":"LENALIDOMIDE","submissionType":"SUPPL","submissionNumber":"70","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-22","drugIds":["lenalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA219745","sponsor":"ACCORD","brand":"CAMCEVI ETM","generic":"LEUPROLIDE MESYLATE","submissionType":"SUPPL","submissionNumber":"1","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-21","drugIds":["goserelin","leuprolide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA212327","sponsor":"BRISTOL-MYERS","brand":"INREBIC","generic":"FEDRATINIB HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-20","drugIds":["fedratinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA217180","sponsor":"INCYTE CORP","brand":"JAKAFI XR","generic":"RUXOLITINIB","submissionType":"SUPPL","submissionNumber":"1","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-20","drugIds":["ruxolitinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA209526","sponsor":"MSN","brand":"CARFILZOMIB","generic":"CARFILZOMIB","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-20","drugIds":["carfilzomib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA202192","sponsor":"INCYTE CORP","brand":"JAKAFI","generic":"RUXOLITINIB","submissionType":"SUPPL","submissionNumber":"33","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-20","drugIds":["ruxolitinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA216873","sponsor":"GLAXOSMITHKLINE","brand":"OJJAARA","generic":"MOMELOTINIB","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-20","drugIds":["momelotinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA208712","sponsor":"SOBI","brand":"VONJO","generic":"PACRITINIB","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-20","drugIds":["pacritinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA204549","sponsor":"ACTAVIS INC","brand":"GEMCITABINE HYDROCHLORIDE","generic":"GEMCITABINE HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-17","drugIds":["gemcitabine-nab-paclitaxel","gemcitabine-cisplatin","gemcitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA209192","sponsor":"FRESENIUS KABI USA","brand":"DEXAMETHASONE SODIUM PHOSPHATE","generic":"DEXAMETHASONE SODIUM PHOSPHATE","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-17","drugIds":["dexamethasone"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA217677","sponsor":"SPRINGWORKS","brand":"OGSIVEO","generic":"NIROGACESTAT","submissionType":"SUPPL","submissionNumber":"8","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-17","drugIds":["nirogacestat"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA103353","sponsor":"AMGEN","brand":"NEUPOGEN","generic":"FILGRASTIM","submissionType":"SUPPL","submissionNumber":"5202","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-16","drugIds":["filgrastim"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA205919","sponsor":"NOVA LABS LTD","brand":"PURIXAN","generic":"MERCAPTOPURINE","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-16","drugIds":["mercaptopurine"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA219908","sponsor":"CELCUITY","brand":"REVTORPYK","generic":"GEDATOLISIB","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-07-14","drugIds":["gedatolisib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210725","sponsor":"APOTEX","brand":"AFATINIB DIMALEATE","generic":"AFATINIB DIMALEATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-14","drugIds":["afatinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA218160","sponsor":"ELI LILLY AND CO","brand":"RETEVMO","generic":"SELPERCATINIB","submissionType":"SUPPL","submissionNumber":"7","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-14","drugIds":["selpercatinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210750","sponsor":"HETERO LABS LTD V","brand":"AFATINIB DIMALEATE","generic":"AFATINIB","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-14","drugIds":["afatinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA213246","sponsor":"ELI LILLY AND CO","brand":"RETEVMO","generic":"SELPERCATINIB","submissionType":"SUPPL","submissionNumber":"17","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-14","drugIds":["selpercatinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA021588","sponsor":"NOVARTIS","brand":"GLEEVEC","generic":"IMATINIB MESYLATE","submissionType":"SUPPL","submissionNumber":"67","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-13","drugIds":["imatinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA208716","sponsor":"ELI LILLY AND CO","brand":"VERZENIO","generic":"ABEMACICLIB","submissionType":"SUPPL","submissionNumber":"21","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-13","drugIds":["abemaciclib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761467","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA QLEX","generic":"PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH","submissionType":"SUPPL","submissionNumber":"12","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-10","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761137","sponsor":"ASTELLAS","brand":"PADCEV","generic":"ENFORTUMAB VEDOTIN","submissionType":"SUPPL","submissionNumber":"37","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-10","drugIds":["enfortumab-vedotin"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125514","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA","generic":"PEMBROLIZUMAB","submissionType":"SUPPL","submissionNumber":"194","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-10","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA212555","sponsor":"GLENMARK PHARMS LTD","brand":"NINTEDANIB ESYLATE","generic":"NINTEDANIB","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-09","drugIds":["nintedanib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761445","sponsor":"SANOFI-AVENTIS U.S. LLC","brand":"SARCLISA ESCENA","generic":"ISATUXIMAB-IRFC","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 3","classDescription":"Type 3 - New Dosage Form","statusDate":"2026-07-09","drugIds":["isatuximab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA218472","sponsor":"HUMANWELL PURACAP","brand":"NINTEDANIB ESYLATE","generic":"NINTEDANIB","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-07-09","drugIds":["nintedanib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210203","sponsor":"HETERO LABS LTD V","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-01","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA209935","sponsor":"NOVARTIS","brand":"KISQALI FEMARA CO-PACK (COPACKAGED)","generic":"LETROZOLE / RIBOCICLIB SUCCINATE","submissionType":"SUPPL","submissionNumber":"33","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-01","drugIds":["ribociclib","letrozole"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA211724","sponsor":"RELIANCE LIFE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-07-01","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA209092","sponsor":"NOVARTIS","brand":"KISQALI","generic":"RIBOCICLIB","submissionType":"SUPPL","submissionNumber":"27","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-07-01","drugIds":["ribociclib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219464","sponsor":"I3 PHARMS","brand":"EVEROLIMUS","generic":"EVEROLIMUS","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-30","drugIds":["everolimus"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA215309","sponsor":"INCYTE CORP","brand":"OPZELURA","generic":"RUXOLITINIB","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-30","drugIds":["ruxolitinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA210951","sponsor":"JANSSEN BIOTECH","brand":"ERLEADA","generic":"APALUTAMIDE","submissionType":"SUPPL","submissionNumber":"24","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-29","drugIds":["apalutamide"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761088","sponsor":"CELLTRION INC","brand":"TRUXIMA","generic":"RITUXIMAB-ABBS","submissionType":"SUPPL","submissionNumber":"35","classCode":"BIOEQUIV","classDescription":"Bioequivalence","statusDate":"2026-06-29","drugIds":["rituximab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA201848","sponsor":"DELCATH SYSTEMS INC","brand":"HEPZATO","generic":"MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","submissionType":"SUPPL","submissionNumber":"19","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-29","drugIds":["hepzato","melphalan"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA021288","sponsor":"VERITY","brand":"TRELSTAR","generic":"TRIPTORELIN PAMOATE","submissionType":"SUPPL","submissionNumber":"47","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-26","drugIds":["triptorelin"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA022437","sponsor":"VERITY","brand":"TRELSTAR","generic":"TRIPTORELIN PAMOATE","submissionType":"SUPPL","submissionNumber":"27","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-26","drugIds":["triptorelin"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761113","sponsor":"SANOFI AVENTIS US","brand":"SARCLISA","generic":"ISATUXIMAB","submissionType":"SUPPL","submissionNumber":"18","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-26","drugIds":["isatuximab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA218035","sponsor":"DR REDDYS","brand":"PREDNISONE","generic":"PREDNISONE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-26","drugIds":["prednisone"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA020715","sponsor":"VERITY","brand":"TRELSTAR","generic":"TRIPTORELIN PAMOATE","submissionType":"SUPPL","submissionNumber":"52","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-26","drugIds":["triptorelin"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA219304","sponsor":"DECIPHERA PHARMS","brand":"ROMVIMZA","generic":"VIMSELTINIB","submissionType":"SUPPL","submissionNumber":"2","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-26","drugIds":["vimseltinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761166","sponsor":"PHARMAESSENTIA CORP","brand":"BESREMI","generic":"ROPEGINTERFERON ALFA-2B","submissionType":"SUPPL","submissionNumber":"10","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-26","drugIds":["ropeginterferon-alfa-2b"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219134","sponsor":"TEVA PHARMS INC","brand":"NILOTINIB HYDROCHLORIDE","generic":"NILOTINIB HYDROCHLORIDE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-26","drugIds":["nilotinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA091308","sponsor":"APOTEX INC","brand":"IMIQUIMOD","generic":"IMIQUIMOD","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-24","drugIds":["imiquimod"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761467","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA QLEX","generic":"PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH","submissionType":"SUPPL","submissionNumber":"4","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-24","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761115","sponsor":"IMMUNOMEDICS INC","brand":"TRODELVY","generic":"SACITUZUMAB GOVITECAN","submissionType":"SUPPL","submissionNumber":"64","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-24","drugIds":["sacituzumab-govitecan"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761115","sponsor":"IMMUNOMEDICS INC","brand":"TRODELVY","generic":"SACITUZUMAB GOVITECAN","submissionType":"SUPPL","submissionNumber":"63","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-24","drugIds":["sacituzumab-govitecan"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA217639","sponsor":"STEMLINE THERAP","brand":"ORSERDU","generic":"ELACESTRANT","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-24","drugIds":["elacestrant"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA207103","sponsor":"PFIZER","brand":"IBRANCE","generic":"PALBOCICLIB","submissionType":"SUPPL","submissionNumber":"24","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-24","drugIds":["palbociclib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125514","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA","generic":"PEMBROLIZUMAB","submissionType":"SUPPL","submissionNumber":"187","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-24","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA212436","sponsor":"PFIZER","brand":"IBRANCE","generic":"PALBOCICLIB","submissionType":"SUPPL","submissionNumber":"12","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-24","drugIds":["palbociclib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA220436","sponsor":"AVYXA HOLDINGS","brand":"NAVITRUX","generic":"FOSAPREPITANT","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 5","classDescription":"Type 5 - New Formulation or New Manufacturer","statusDate":"2026-06-24","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA125320","sponsor":"AMGEN","brand":"PROLIA","generic":"DENOSUMAB","submissionType":"SUPPL","submissionNumber":"225","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-23","drugIds":["denosumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA125320","sponsor":"AMGEN","brand":"PROLIA","generic":"DENOSUMAB","submissionType":"SUPPL","submissionNumber":"224","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-23","drugIds":["denosumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761309","sponsor":"GENENTECH INC","brand":"COLUMVI","generic":"GLOFITAMAB","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-22","drugIds":["glofitamab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761263","sponsor":"GENENTECH INC","brand":"LUNSUMIO VELO","generic":"MOSUNETUZUMAB","submissionType":"SUPPL","submissionNumber":"10","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-18","drugIds":["mosunetuzumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761324","sponsor":"GENMAB US, INC.","brand":"EPKINLY","generic":"EPCORITAMAB-BYSP","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-17","drugIds":["epcoritamab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA218754","sponsor":"AZURITY","brand":"APREPITANT","generic":"APREPITANT","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 5","classDescription":"Type 5 - New Formulation or New Manufacturer","statusDate":"2026-06-16","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA201452","sponsor":"ARROW INTL","brand":"LENALIDOMIDE","generic":"LENALIDOMIDE","submissionType":"SUPPL","submissionNumber":"3","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-15","drugIds":["lenalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA201452","sponsor":"ARROW INTL","brand":"LENALIDOMIDE","generic":"LENALIDOMIDE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-15","drugIds":["lenalidomide"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA215383","sponsor":"MERCK SHARP DOHME","brand":"WELIREG","generic":"BELZUTIFAN","submissionType":"SUPPL","submissionNumber":"15","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-12","drugIds":["belzutifan"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761467","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA QLEX","generic":"PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH","submissionType":"SUPPL","submissionNumber":"9","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-12","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA209624","sponsor":"MSN","brand":"BOSUTINIB","generic":"BOSUTINIB","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-12","drugIds":["bosutinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125377","sponsor":"BRISTOL MYERS SQUIBB","brand":"YERVOY","generic":"IPILIMUMAB","submissionType":"SUPPL","submissionNumber":"138","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-12","drugIds":["ipilimumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA125514","sponsor":"MERCK SHARP DOHME","brand":"KEYTRUDA","generic":"PEMBROLIZUMAB","submissionType":"SUPPL","submissionNumber":"192","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-12","drugIds":["pembrolizumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA218197","sponsor":"ASTRAZENECA","brand":"TRUQAP","generic":"CAPIVASERTIB","submissionType":"SUPPL","submissionNumber":"4","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-12","drugIds":["capivasertib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA208434","sponsor":"HOFFMANN-LA ROCHE","brand":"ALECENSA","generic":"ALECTINIB HYDROCHLORIDE","submissionType":"SUPPL","submissionNumber":"16","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-06-11","drugIds":["alectinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA214590","sponsor":"ALEMBIC","brand":"TRETINOIN","generic":"TRETINOIN","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-11","drugIds":["tretinoin-atra"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA218784","sponsor":"SERVIER","brand":"VORANIGO","generic":"VORASIDENIB","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-10","drugIds":["vorasidenib"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA212143","sponsor":"CHIA TAI TIANQING","brand":"FOSAPREPITANT DIMEGLUMINE","generic":"FOSAPREPITANT DIMEGLUMINE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-10","drugIds":["aprepitant"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA204949","sponsor":"PHARMOBEDIENT","brand":"AZACITIDINE","generic":"AZACITIDINE","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["azacitidine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA204949","sponsor":"PHARMOBEDIENT","brand":"AZACITIDINE","generic":"AZACITIDINE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["azacitidine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA204949","sponsor":"PHARMOBEDIENT","brand":"AZACITIDINE","generic":"AZACITIDINE","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["azacitidine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA202593","sponsor":"ACCORD HLTHCARE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"12","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA202593","sponsor":"ACCORD HLTHCARE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"10","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA202593","sponsor":"ACCORD HLTHCARE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"17","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA202593","sponsor":"ACCORD HLTHCARE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA202593","sponsor":"ACCORD HLTHCARE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA202593","sponsor":"ACCORD HLTHCARE","brand":"CAPECITABINE","generic":"CAPECITABINE","submissionType":"SUPPL","submissionNumber":"2","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-09","drugIds":["capecitabine-temozolomide","capecitabine"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761234","sponsor":"BRISTOL MYERS SQUIBB","brand":"OPDUALAG","generic":"NIVOLUMAB AND RELATLIMAB-RMBW","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-08","drugIds":["relatlimab-nivolumab","nivolumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA208371","sponsor":"RISING","brand":"ABIRATERONE ACETATE","generic":"ABIRATERONE ACETATE","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-05","drugIds":["abiraterone"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA206228","sponsor":"ZYDUS PHARMS","brand":"ARSENIC TRIOXIDE","generic":"ARSENIC TRIOXIDE","submissionType":"SUPPL","submissionNumber":"13","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-02","drugIds":["arsenic-trioxide"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA219099","sponsor":"AMNEAL","brand":"ROMIDEPSIN","generic":"ROMIDEPSIN","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-02","drugIds":["romidepsin"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA022334","sponsor":"NOVARTIS","brand":"AFINITOR","generic":"EVEROLIMUS","submissionType":"SUPPL","submissionNumber":"55","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-01","drugIds":["everolimus"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA217085","sponsor":"NATCO","brand":"ERIBULIN MESYLATE","generic":"ERIBULIN MESYLATE","submissionType":"ORIG","submissionNumber":"1","classCode":"UNKNOWN","statusDate":"2026-06-01","drugIds":["eribulin"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA203985","sponsor":"NOVARTIS PHARM","brand":"AFINITOR DISPERZ","generic":"EVEROLIMUS","submissionType":"SUPPL","submissionNumber":"28","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-06-01","drugIds":["everolimus"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA217379","sponsor":"CYCLE","brand":"CAVHANZA","generic":"NILOTINIB","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 5","classDescription":"Type 5 - New Formulation or New Manufacturer","statusDate":"2026-05-29","drugIds":["nilotinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761036","sponsor":"JANSSEN BIOTECH","brand":"DARZALEX","generic":"DARATUMUMAB","submissionType":"SUPPL","submissionNumber":"61","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-28","drugIds":["daratumumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761069","sponsor":"ASTRAZENECA UK LTD","brand":"IMFINZI","generic":"DURVALUMAB","submissionType":"SUPPL","submissionNumber":"53","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-05-28","drugIds":["durvalumab"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761309","sponsor":"GENENTECH INC","brand":"COLUMVI","generic":"GLOFITAMAB","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-28","drugIds":["glofitamab"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA201848","sponsor":"DELCATH SYSTEMS INC","brand":"HEPZATO","generic":"MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","submissionType":"SUPPL","submissionNumber":"16","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-28","drugIds":["hepzato","melphalan"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA040385","sponsor":"BARR","brand":"TREXALL","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"28","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213343","sponsor":"ACCORD HLTHCARE","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA213362","sponsor":"DAITO","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761460","sponsor":"ABBVIE INC","brand":"DECNUPAZ","generic":"PIVEKIMAB SUNIRINE-PVZY","submissionType":"ORIG","submissionNumber":"1","classCode":"TYPE 1","classDescription":"Type 1 - New Molecular Entity","statusDate":"2026-05-27","drugIds":["pivekimab-sunirine"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA217552","sponsor":"ALEMBIC","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA008085","sponsor":"STRIDES PHARMA INTL","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"72","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA207812","sponsor":"ZYDUS PHARMS","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA081099","sponsor":"BARR","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"53","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210040","sponsor":"AMNEAL PHARMS","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"15","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA216453","sponsor":"ELITE LABS INC","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"3","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA081235","sponsor":"MYLAN","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"36","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA201749","sponsor":"SUN PHARM","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"11","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA218197","sponsor":"ASTRAZENECA","brand":"TRUQAP","generic":"CAPIVASERTIB","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["capivasertib"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA212479","sponsor":"SHORLA","brand":"JYLAMVO","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"9","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA040054","sponsor":"HIKMA","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE SODIUM","submissionType":"SUPPL","submissionNumber":"19","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA210454","sponsor":"EUGIA PHARMA","brand":"METHOTREXATE SODIUM","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA208400","sponsor":"AZURITY","brand":"XATMEP","generic":"METHOTREXATE","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-27","drugIds":["methotrexate"],"firstSeen":"2026-09-09"},{"applicationNumber":"NDA213756","sponsor":"ASTRAZENECA","brand":"KOSELUGO","generic":"SELUMETINIB","submissionType":"SUPPL","submissionNumber":"7","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-26","drugIds":["selumetinib"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA219943","sponsor":"ASTRAZENECA","brand":"KOSELUGO","generic":"SELUMETINIB","submissionType":"SUPPL","submissionNumber":"3","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-26","drugIds":["selumetinib"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761354","sponsor":"BIOGEN MA","brand":"TOFIDENCE","generic":"TOCILIZUMAB","submissionType":"SUPPL","submissionNumber":"9","classCode":"BIOSIMILAR","statusDate":"2026-05-22","drugIds":["tocilizumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761394","sponsor":"DAIICHI SANKYO INC","brand":"DATROWAY","generic":"DATOPOTAMAB DERUXTECAN","submissionType":"SUPPL","submissionNumber":"3","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-05-22","drugIds":["datopotamab-deruxtecan"],"firstSeen":"2026-09-09"},{"applicationNumber":"ANDA212975","sponsor":"HETERO LABS LTD V","brand":"IMATINIB MESYLATE","generic":"IMATINIB MESYLATE","submissionType":"SUPPL","submissionNumber":"4","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-22","drugIds":["imatinib"],"firstSeen":"2026-09-09"},{"applicationNumber":"BLA761111","sponsor":"HOSPIRA INC","brand":"NYVEPRIA","generic":"PEGFILGRASTIM-APGF","submissionType":"SUPPL","submissionNumber":"10","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-21","drugIds":["pegfilgrastim"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761275","sponsor":"FRESENIUS KABI USA","brand":"TYENNE","generic":"TOCILIZUMAB-AAZG","submissionType":"SUPPL","submissionNumber":"22","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-21","drugIds":["tocilizumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"ANDA209125","sponsor":"EUGIA PHARMA","brand":"ZOLEDRONIC ACID","generic":"ZOLEDRONIC ACID","submissionType":"SUPPL","submissionNumber":"5","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-20","drugIds":["zoledronic-acid"],"firstSeen":"2026-09-16"},{"applicationNumber":"BLA761449","sponsor":"FRESENIUS KABI USA","brand":"TYENNE","generic":"TOCILIZUMAB-AAZG","submissionType":"SUPPL","submissionNumber":"6","classCode":"LABELING","classDescription":"Labeling","statusDate":"2026-05-20","drugIds":["tocilizumab"],"firstSeen":"2026-09-16"},{"applicationNumber":"NDA208573","sponsor":"ABBVIE","brand":"VENCLEXTA","generic":"VENETOCLAX","submissionType":"SUPPL","submissionNumber":"32","classCode":"EFFICACY","classDescription":"Efficacy","statusDate":"2026-05-20","drugIds":["venetoclax"],"firstSeen":"2026-09-09"}],"notInCorpus":[{"date":"2026-06-30","title":"FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched","firstSeen":"2026-09-09"}],"errors":[]}