FDA PDUFA Calendar 2026
Upcoming FDA drug-approval decision dates (PDUFA target action dates) — 88 decisions across 67 companies. Browse by month, or see the next decisions below.
21
Next 90 days
38
Next 6 months
67
Companies
88
Decisions tracked
What you can answer with this page
A curated calendar of upcoming FDA drug-approval decisions — every PDUFA target action date sourced to a company filing or FDA notice, browsable by month, with the drug, company, and indication.
What is a PDUFA date?
The PDUFA (Prescription Drug User Fee Act) target action date is the deadline by which the FDA aims to finish reviewing a drug application and issue a decision — an approval, a complete response letter (CRL), or a delay. The FDA sets it when it accepts the application for review.
What FDA drug-approval decisions are coming up?
The "Next decisions" table above lists the nearest PDUFA target action dates in chronological order, with the drug, company, and indication. Browse by month below for the full calendar.
How reliable are PDUFA dates?
PDUFA dates are set by the FDA, but they can move: the agency can extend a review (typically by three months) when a company submits major new information, and decisions occasionally come early. Treat each date as the current target rather than a guarantee.
Where does this data come from?
Dates are compiled from primary sources — company press releases, SEC 8-K / 6-K filings, and FDA notices — plus curated tracking of the review calendar. Where an entry has a cited source, its detail page links to it.
Can I subscribe to the PDUFA calendar?
Yes — subscribe to the iCal feed to add upcoming FDA decision dates to Google Calendar, Apple Calendar, or Outlook.
Do you cover past FDA decisions too?
Yes — recent months stay browsable below the upcoming calendar, so you can look back at target action dates that have already passed.
Next decisions
| Target date | Drug | Company | Indication |
|---|---|---|---|
| Jul 23, 2026 | Rivoceranib + camrelizumab | Elevar Therapeutics, Inc. | Unresectable hepatocellular carcinoma (1L systemic) |
| Jul 23, 2026 | Rivoceranib + camrelizumab | Elevar Therapeutics, Inc. | — |
| Jul 26, 2026 | Tavapadon | AbbVie Inc. (ABBV) | Parkinson's disease (monotherapy and adjunct to levodopa) |
| Jul 30, 2026 | Pivekimab sunirine (PVEK) | AbbVie Inc. (ABBV) | Blastic plasmacytoid dendritic cell neoplasm (BPDCN) |
| Aug 5, 2026 | mRNA-1010 | Moderna, Inc. (MRNA) | Seasonal flu |
| Aug 10, 2026 | Oveporexton (TAK-861) | Takeda Pharmaceutical Co., Ltd. (TAK) | Narcolepsy type 1 (excessive daytime sleepiness) |
| Aug 13, 2026 | LNTH | Lantheus Holdings, Inc. (LNTH) | — |
| Aug 17, 2026 | Iberdomide + daratumumab/dexamethasone | Bristol-Myers Squibb Company (BMY) | Relapsed or refractory multiple myeloma |
| Aug 19, 2026 | Garetosmab | Regeneron Pharmaceuticals, Inc. (REGN) | Fibrodysplasia ossificans progressiva (FOP) in adults |
| Aug 22, 2026 | Deramiocel (CAP-1002) | Capricor Therapeutics, Inc. (CAPR) | Duchenne muscular dystrophy (DMD) cardiomyopathy |
| Aug 23, 2026 | DTX401 (pariglasgene brecaparvovec) | Ultragenyx Pharmaceutical Inc. (RARE) | glycogen storage disease type Ia (GSDIa) |
| Aug 25, 2026 | ZIIHERA (zanidatamab) | Jazz Pharmaceuticals plc (JAZZ) | first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) |
| Aug 27, 2026 | bictegravir and lenacapavir (BIC LEN) | GILEAD SCIENCES, INC. (GILD) | virologically suppressed people with HIV |
| Sep 2, 2026 | Rusfertide | Takeda Pharmaceutical Co., Ltd. (TAK) | Polycythemia vera (PV) |
| Sep 11, 2026 | Pixclara (Floretyrosine F 18 or 18F-FET) | Telix Pharmaceuticals Ltd (TLX) | glioma (brain cancer) |
| Sep 18, 2026 | zidesamtinib | Nuvalent, Inc. (NUVL) | locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI |
| Sep 21, 2026 | Winrevair (sotatercept) | Merck & Co., Inc. (MRK) | Recently diagnosed pulmonary arterial hypertension (PAH, HYPERION label update) |
| Sep 30, 2026 | Brepocitinib | Roivant Sciences Ltd. (ROIV) | Dermatomyositis |
| Sep 30, 2026 | apitegromab | Scholar Rock Holding Corp (SRRK) | spinal muscular atrophy (SMA) |
| Oct 4, 2026 | Welireg (belzutifan) + Lenvima (lenvatinib) | Merck & Co., Inc. (MRK) | Previously treated advanced ccRCC post-PD-1/PD-L1 therapy |
| Oct 10, 2026 | Ifinatamab deruxtecan (I-DXd) | Merck & Co., Inc. (MRK) | Extensive-stage small cell lung cancer (ES-SCLC) after platinum chemo |
| Oct 17, 2026 | Phentolamine ophthalmic solution 0.75% | Opus Genetics, Inc. (IRD) | Presbyopia |
| Oct 18, 2026 | CagriSema (cagrilintide + semaglutide) | Novo Nordisk A/S (NVO) | Chronic weight management in adults with obesity or overweight |
| Oct 24, 2026 | separate | Pharming Group N.V. (PHAR) | — |
| Oct 30, 2026 | INO-3107 | Inovio Pharmaceuticals, Inc. (INO) | Recurrent Respiratory Papillomatosis (RRP) in adults |
| Nov 14, 2026 | Ivonescimab + chemotherapy | Summit Therapeutics Inc. (SMMT) | EGFR-mutated NSCLC post-TKI therapy (combination with platinum-doublet chemo) |
| Nov 14, 2026 | ivonescimab | Summit Therapeutics Inc. (SMMT) | EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy |
| Nov 14, 2026 | IGALMI | BioXcel Therapeutics, Inc. (BTAI) | acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting |
| Nov 14, 2026 | aficamten | CYTOKINETICS INC (CYTK) | — |
| Dec 3, 2026 | Zanzalintinib (XL-092) + atezolizumab | Exelixis, Inc. (EXEL) | Pretreated metastatic colorectal cancer (mCRC) |
Browse by month
Upcoming
July 2026
8 decisions
August 2026
9 decisions
September 2026
6 decisions
October 2026
6 decisions
November 2026
4 decisions
December 2026
9 decisions
January 2027
1 decision
February 2027
1 decision
Recent
About this calendar
PDUFA target action dates are compiled from primary sources — company press releases, SEC filings (8-K / 6-K), and FDA notices — with cited sources linked on an entry's detail page where available. Dates can shift: the FDA can extend a review, and decisions sometimes arrive early, so treat every date as the current target rather than a guarantee.
For the interactive month-by-month view, see the PDUFA dashboard. For upcoming Phase 3 clinical-trial readouts, see the readout calendar.