FDA approval letters: 103 FDA decisions, each dated by the FDA's own record

What the FDA approved, day by day (last 60 days, by FDA action date)

November 10, 2026: the FDA approved Pimjetmi (pimicotinib) (MKKGY), FDA oncology approval notification, November 10, 2026.

November 9, 2026: the FDA approved Sunharbo (asundexian) (BAYRY), FDA press announcement, November 9, 2026.

October 30, 2026: the FDA approved VOCERYQ (INO-3107) (INO), FDA press announcement, October 30, 2026 (CBER product; not in Drugs@FDA).

October 21, 2026: the FDA approved Ultomiris (ravulizumab) - IgA nephropathy (AZN), BLA 761108 S-046.

October 20, 2026: the FDA approved Hibsago (bepirovirsen) (GSK), NDA 221276 ORIG-1.

October 19, 2026: the FDA approved Jemperli (dostarlimab-gxly) (GSK), BLA 761174 S-015.

October 16, 2026: the FDA approved Phentolamine ophthalmic solution 0.75% (IRD/VTRS), NDA 217064 S-005.

October 15, 2026: the FDA approved Enspryng (satralizumab) (RHHBY), BLA 761149 S-008.

October 14, 2026: the FDA approved ANKTIVA (N-803) + BCG (IBRX), FDA approval notification (sBLA, BLA 761336; letter not yet on Drugs@FDA).

October 9, 2026: the FDA approved Repatha (evolocumab) - cardiovascular risk reduction label e (AMGN), BLA 125522 SUPPL-47.

October 8, 2026: the FDA approved Tecentriq (atezolizumab) (RHHBY), FDA approval notification (sBLA; letter not yet on Drugs@FDA); Weltruza (olanzapine) extended-release injectable suspension (TEVA), NDA 219007 ORIG-1.

October 7, 2026: the FDA approved Tukysa (tucatinib) + trastuzumab + pertuzumab - HER2+ metast (PFE), NDA 213411 SUPPL-10.

October 6, 2026: the FDA approved Rhapsido (remibrutinib) (NVS), NDA 218436 S-001 (openFDA AP 2026-10-06; letter listed, not yet posted).

October 2, 2026: the FDA approved Jaypirca (pirtobrutinib) (LLY), FDA approval notification, NDA 216059.

September 30, 2026: the FDA approved Camzyos (mavacamten) - pediatric oHCM (SCOUT-HCM) (BMY), NDA 214998 SUPPL-13.

September 25, 2026: the FDA approved Gazyva (obinutuzumab) (RHHBY), BLA 125486 SUPPL-43; Atebrioz (zilurgisertib) (INCY/MIRM), NDA 221198 ORIG-1; JUVMO (tavapadon) (ABBV), NDA 220415 ORIG-1, announced Sep 28, 2026; Olumiant (baricitinib) (LLY), NDA 207924 SUPPL-9; Degevma (denosumab-adet), biosimilar to and interchangeable (TEVA), BLA 761481 ORIG-1.

September 24, 2026: the FDA approved Welireg (belzutifan) plus Lenvima (lenvatinib) (MRK), NDA 215383 SUPPL-13.

September 23, 2026: the FDA approved Onswik (insulin efsitora alfa-gobe) (LLY), BLA 761408 ORIG-1.

September 21, 2026: the FDA approved WINREVAIR (sotatercept-csrk) (MRK), BLA 761363 S-017, announced Sep 22, 2026.

September 18, 2026: the FDA approved Inluriyo (imlunestrant) + Verzenio (abemaciclib) (LLY), NDA 218881 S-001.

September 17, 2026: the FDA approved FAYUVI (rebisufligene etisparvovec-hopf; UX111 / ABO-102) (RARE), CBER approval letter (FAYUVI).

September 16, 2026: the FDA approved KERENDIA (finerenone), T1D-CKD (BAYRY), NDA 215341 S-011; IBTROZI (taletrectinib) sNDA (NUVB), NDA 219713 S-004.

2026 · 103 FDA actions

Questions

Where can I find an FDA approval letter?
For drugs reviewed by CDER, the FDA posts the approval letter in Drugs@FDA under the application number, usually within a few days of the action; biologics reviewed by CBER have their letters on the product's page at fda.gov. This page links the letter for every decision pdufa.bio tracks.

What date does an FDA approval letter show?
The day the FDA acted. It is often not the day the company announced the decision: of the 103 actions listed here, 25 were announced by the sponsor on a later day than the FDA's letter or record, typically the next business day.

Why does pdufa.bio date decisions by the FDA letter rather than the press release?
Because the letter is the FDA's record of when it acted, and a press release is the company's record of when it chose to announce. Our decision-timing statistic compares each action date with the PDUFA goal date, so it uses the FDA's date, and every row here links the document it comes from.

Every released Complete Response Letter · the decisions archive · does the FDA decide on the PDUFA date?

Historical record, linked to the FDA's documents. Not investment advice.