FDA PDUFA Calendar 2026
Upcoming FDA drug-approval decision dates (PDUFA target action dates) — 47 decisions across 40 companies. Browse by month, or see the next decisions below.
36
Next 90 days
45
Next 6 months
40
Companies
47
Upcoming decisions
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 |
|---|---|---|---|
| Sep 21, 2026 | Winrevair (sotatercept) | Merck & Co., Inc. (MRK) | Recently diagnosed pulmonary arterial hypertension (PAH, HYPERION label update) |
| Sep 22, 2026 | Zilganersen | Ionis Pharmaceuticals, Inc. (IONS) | Alexander disease (AxD) |
| Sep 26, 2026 | Zilurgisertib | Mirum Pharmaceuticals, Inc. (MIRM) | Fibrodysplasia ossificans progressiva (FOP), patients 12 years and older |
| Sep 27, 2026 | Lirafugratinib (RLY-4008) | Elevar Therapeutics, Inc. | Previously treated FGFR2 fusion/rearrangement-positive cholangiocarcinoma (second-line) |
| Sep 28, 2026 | Emcitate (tiratricol) | Egetis Therapeutics AB (EGTX) | MCT8 deficiency (monocarboxylate transporter 8 deficiency) |
| Sep 28, 2026 | Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% — photodynamic therapy | Biofrontera Inc. (BFRI) | Superficial basal cell carcinoma (sBCC) |
| Sep 30, 2026 | Brepocitinib | Roivant Sciences Ltd. (ROIV) | Dermatomyositis |
| Sep 30, 2026 | apitegromab | Scholar Rock Holding Corp (SRRK) | spinal muscular atrophy (SMA) |
| Sep 30, 2026 | Camzyos (mavacamten) | Bristol Myers Squibb (BMY) | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adolescents (12 to <18 years) |
| Oct 4, 2026 | Welireg (belzutifan) + Lenvima (lenvatinib) | Merck & Co., Inc. (MRK) | Previously treated advanced ccRCC post-PD-1/PD-L1 therapy |
| Oct 9, 2026 | Tecentriq (atezolizumab) + chemotherapy | Genentech (Roche) (RHHBY) | Adjuvant stage III dMMR/MSI-H colon cancer |
| Oct 10, 2026 | Ifinatamab deruxtecan (I-DXd) | Merck & Co., Inc. (MRK) | Extensive-stage small cell lung cancer (ES-SCLC) after platinum chemo |
| Oct 15, 2026 | Enspryng (satralizumab) | Genentech (Roche) (RHHBY) | Thyroid eye disease (TED) |
| 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 | Leniolisib (Joenja) | Pharming Group N.V. (PHAR) | Activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years |
| Oct 26, 2026 | Bepirovirsen | GSK plc (GSK) | Chronic hepatitis B (CHB) in adults |
| Oct 30, 2026 | INO-3107 | Inovio Pharmaceuticals, Inc. (INO) | Recurrent Respiratory Papillomatosis (RRP) in adults |
| Nov 1, 2026 | Mitapivat (PYRUKYND) | Agios Pharmaceuticals, Inc. (AGIO) | Sickle cell disease in patients aged 16 and older (accelerated approval pathway) |
| Nov 14, 2026 | Ivonescimab + chemotherapy | Summit Therapeutics Inc. (SMMT) | EGFR-mutated NSCLC post-TKI therapy (combination with platinum-doublet chemo) |
| 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 | MYQORZO (aficamten) | Cytokinetics, Incorporated (CYTK) | Obstructive hypertrophic cardiomyopathy - label expansion to include the MAPLE-HCM Phase 3 results (aficamten monotherapy vs metoprolol monotherapy) |
| Nov 14, 2026 | aficamten | CYTOKINETICS INC (CYTK) | — |
| Nov 22, 2026 | MOLBREEVI (molgramostim) inhalation solution | Savara Inc. (SVRA) | Autoimmune pulmonary alveolar proteinosis (aPAP) |
| Nov 22, 2026 | Deramiocel | CAPRICOR THERAPEUTICS, INC. (CAPR) | — |
| Nov 27, 2026 | BBP-418 (ribitol) | BridgeBio Pharma, Inc. (BBIO) | Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) |
| Nov 27, 2026 | Neladalkib (NVL-655) | Nuvalent, Inc. (NUVL) | TKI pre-treated advanced ALK-positive non-small cell lung cancer (NSCLC) |
| Nov 28, 2026 | D-PLEX100 | PolyPid Ltd. (PYPD) | Prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery |
| Nov 30, 2026 | Povetacicept (ALPN-303) | Vertex Pharmaceuticals Incorporated (VRTX) | IgA nephropathy (IgAN) in adults (accelerated approval pathway) |
| Nov 30, 2026 | Giredestrant | Genentech, Inc. (Roche) (RHHBY) | Adjuvant treatment of ER-positive, HER2-negative stage I, II and III early breast cancer |
Browse by month
Upcoming
September 2026
14 decisions
October 2026
9 decisions
November 2026
13 decisions
December 2026
9 decisions
January 2027
4 decisions
February 2027
1 decision
April 2027
1 decision
May 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.