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Home › Decisions › FDA approval letters

FDA approval letters: 38 FDA decisions, each dated by the FDA's own record

Updated ยทnext FDA decision on the calendar
Every FDA decision this site dates is dated from the FDA's record of the action, not from the company's press release: the approval letter in Drugs@FDA (35), the FDA's approval notice or letter for biologics reviewed by CBER (1), or the Complete Response Letter the FDA released (2). 7 of the 38 were announced by the company on a later day than the FDA acted; those rows show both dates. Newest first. This is the evidence behind the decision-timing study.

2026 · 38 FDA actions

FDA action dateDrugSponsorFDA recordAnnouncedOn this site
Sep 21, 2026WINREVAIR (sotatercept-csrk) - (HYPERION)Merck & Co., Inc. (MRK)Approval letter
BLA 761363 S-017		Sep 22, 2026MRK
Sep 18, 2026Inluriyo (imlunestrant) + Verzenio (abemaciclib) - (EMBER-3)ELI LILLY & Co (LLY)Approval letter
NDA 218881 S-001		same dayLLY
Sep 17, 2026FAYUVI (rebisufligene etisparvovec-hopf; UX111 / ABO-102)Ultragenyx Pharmaceutical Inc. (RARE)Approval letter
CBER approval letter (FAYUVI)		same dayRARE
Sep 16, 2026KERENDIA (finerenone), T1D-CKDBayer (BAYRY)Approval letter
NDA 215341 S-011		same dayBAYRY
Sep 16, 2026IBTROZI (taletrectinib) sNDANuvation Bio Inc. (NUVB)Approval letter
NDA 219713 S-004		same dayNUVB
Sep 11, 2026Pixclara (floretyrosine F 18; TLX101-Px)Telix Pharmaceuticals Limited (TLX)Approval letter
NDA 218592 ORIG-1		Sep 14, 2026TLX
Sep 11, 2026ISEMBYLD (apitegromab-mstn) - (SAPPHIRE)Scholar Rock Holding Corporation (SRRK)Approval letter
BLA 761463 ORIG-1		same daySRRK
Sep 11, 2026Joenja (leniolisib) - paediatric APDSPharming Group N.V. (PHAR)Approval letter
NDA 217759 S-006		same dayPHAR
Sep 9, 2026Ameluz (aminolevulinic acid hydrochloride) with RhodoLED redBiofrontera Inc. (BFRI)Approval letter
NDA 208081 S-040		same dayBFRI
Sep 9, 2026HYRNUO (sevabertinib) - HER2-mutant NSCLCBayer (BAYRY)Approval letter
NDA 219972 S-001		same dayBAYRY
Sep 3, 2026Zilganersen (ION373)Ionis Pharmaceuticals Inc. (IONS)Approval letter
NDA 220210 ORIG-1		same dayIONS
Aug 28, 2026Rusfertide - (REVIVE)Protagonist Therapeutics Inc. (PTGX)Approval letter
NDA 220605 ORIG-1		same dayPTGX
Aug 27, 2026Bictegravir and Lenacapavir - (ARTISTRY-2)Gilead Sciences, Inc. (GILD)Approval letter
NDA 221443 S-001		same dayGILD
Aug 27, 2026Brepocitinib (VALOR)Roivant/Priovant (PFE/ROIV)Approval letter
NDA 220106 ORIG-1		same dayPFE · ROIV
Aug 25, 2026Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01)Jazz Pharmaceuticals plc (JAZZ/ZYME)Approval letter
BLA 761416 S-003		same dayJAZZ · ZYME
Aug 19, 2026DTX401 AAV gene therapy (pariglasgene brecaparvovec)Ultragenyx Pharmaceutical Inc. (RARE)Approval letter
CBER approval letter (GENGLYCOS)		same dayRARE
Aug 19, 2026Garetosmab - (OPTIMA)Regeneron Pharmaceuticals Inc. (REGN)Approval letter
BLA 761508 ORIG-1		same dayREGN
Aug 13, 2026MK-6240Lantheus Holdings Inc. (LNTH)Approval letter
NDA 220496 ORIG-1		same dayLNTH
Aug 13, 2026iberdomide, daratumumab, and dexamethasone vs. daratumumab, Bristol-Myers Squibb Company (BMY)Approval letter
NDA 221075 ORIG-1		same dayBMY
Aug 6, 2026TUDRIQEV (vusolimogene oderparepvec-wtpg) plus nivolumabReplimune Group, Inc. (REPL)FDA approval notice
CBER accelerated approval notice		same dayREPL
Aug 5, 2026MFLUSIVA (Influenza Vaccine, mRNA / mRNA-1010)Moderna Inc. (MRNA)Approval letter
CBER approval letter (MFLUSIVA, BLA 125869)		same dayMRNA
Aug 5, 2026Oveporexton (TAK-861-2001)Takeda Pharmaceutical Co Ltd (TAK)Approval letter
NDA 220860 ORIG-1		same dayTAK
Jul 28, 2026MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestViatris Inc. (VTRS)Approval letter
NDA 219990 ORIG-1		Jul 29, 2026VTRS
Jul 24, 2026CentanafadineOtsuka Pharmaceutical (OTSKY)Approval letter
NDA 218145 ORIG-1		same dayOTSKY
Jul 24, 2026bevacizumabOutlook Therapeutics, Inc. (OTLK)Approval letter
BLA 761320 ORIG-1		same dayOTLK
Jul 23, 2026FUROSCIX ReadyFlow Autoinjector (SCP-111)MannKind Corporation (MNKD)Approval letter
NDA 209988 S-007		Jul 24, 2026MNKD
Jul 22, 2026Zidesamtinib (NVL-520) - (ARROS-1)Nuvalent Inc. (NUVL)Approval letter
NDA 220185 ORIG-1		same dayNUVL
Jul 15, 2026Lipfendra (enlicitide decanoate)Merck & Co., Inc. (MRK)Approval letter
NDA 220848 ORIG-1		Jul 16, 2026MRK
Jul 14, 2026Gedatolisib with Fulvestrant - (VIKTORIA-1)Celcuity Inc. (CELC)Approval letter
NDA 219908 ORIG-1		same dayCELC
Jul 7, 2026Atacicept - (ORIGIN 3)Vera Therapeutics Inc. (VERA)Approval letter
BLA 761486 ORIG-1		same dayVERA
Jun 29, 2026ZORYVE (roflumilast) Cream 0.3%Arcutis Biotherapeutics Inc. (ARQT)Approval letter
NDA 215985 S-015		same dayARQT
Jun 29, 2026Oxylanthanum Carbonate (OLC)Unicycive Therapeutics Inc. (UNCY)Complete Response LetterJun 30, 2026UNCY
Jun 26, 2026Veligrotug (VRDN-001) - (THRIVE-2)Viridian Therapeutics Inc. (VRDN)Approval letter
BLA 761530 ORIG-1		same dayVRDN
Jun 24, 2026Olezarsen - (CORE)Ionis Pharmaceuticals Inc. (IONS)Approval letter
NDA 218614 S-004		same dayIONS
Jun 20, 2026Cytisinicline - (ORCA-3)Achieve Life Sciences Inc. (ACHV)Complete Response LetterJun 22, 2026ACHV
Jun 17, 2026Tebipenem HBr (SPR994) - (PIVOT-PO)GSK plc (GSK/SPRO)Approval letter
NDA 215960 ORIG-1		same dayGSK · SPRO
Jun 12, 2026Truqap - (CAPItello-281)AstraZeneca/Alexion (AZN)Approval letter
NDA 218197 S-004		same dayAZN
Mar 25, 2026Relacorilant + nab-paclitaxel - (ROSELLA)Corcept Therapeutics Inc (CORT)Approval letter
NDA 220641 ORIG-1		same dayCORT

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 38 actions listed here, 7 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.

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