Regulatory timeline
0 dated events across 0 products, including 0 approvals, plus designations, filings, complete response letters, withdrawals, and label changes. Sort by date, filter by type or region, and click through to the product. The FDA approvals feed below is refreshed weekly and shows what is new since the last build and what is not yet in the corpus.
FDA oncology approvals feed
fetched 2026-09-16, previous 2026-09-0919 notifications from the Oncology Center of Excellence since 2026-05-19; 0 new since the last snapshot.
- 2026-09-09grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer
- 2026-09-04grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
- 2026-08-26approves daraxonrasib for metastatic pancreatic adenocarcinoma
- 2026-08-25approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma
- 2026-08-13grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
- 2026-08-06grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
- 2026-07-31approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
- 2026-07-22approves zidesamtinib for ROS1 -positive non-small cell lung cancer
- 2026-07-14approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
- 2026-07-14grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
- 2026-07-10approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
- 2026-07-09approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
Not yet in the corpus
Label and efficacy supplements (openFDA)
193 approved submissions for corpus products since 2026-05-19, from openFDA drugsfda. Efficacy and labelling supplements are listed; manufacturing and REMS changes are not.
- 2026-09-09AMELUZEfficacy · NDA208081
- 2026-09-09HYRNUOEfficacy · NDA219972
- 2026-09-02FYARROLabeling · NDA213312
- 2026-09-02AVTOZMALabeling · BLA761498
- 2026-09-02ETOPOPHOS PRESERVATIVE FREELabeling · NDA020457
- 2026-09-02AVTOZMALabeling · BLA761420
- 2026-09-01KRAZATILabeling · NDA216340
- 2026-09-01NELARABINELabeling · ANDA216038
- 2026-08-31BAVENCIOLabeling · BLA761049
- 2026-08-31IMFINZILabeling · BLA761069
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Feed status and refresh schedule: data currency. Events on product pages are hand-sourced; the feed is a prompt to add them, not a replacement.