FDA PDUFA Calendar 2026
Upcoming FDA drug-approval decision dates (PDUFA target action dates) — 34 decisions across 30 companies. Browse by month, or see the next decisions below.
26
Next 90 days
33
Next 6 months
30
Companies
34
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 |
|---|---|---|---|
| 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 (CAP-1002) | Capricor Therapeutics, Inc. (CAPR) | Duchenne muscular dystrophy (DMD); refined proposed indication focused on upper limb function |
| 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 |
| Nov 30, 2026 | Bezuclastinib + sunitinib | Cogent Biosciences, Inc. (COGT) | Gastrointestinal stromal tumors (GIST) in patients who have received prior treatment with imatinib |
| Dec 3, 2026 | Zanzalintinib (XL-092) + atezolizumab | Exelixis, Inc. (EXEL) | Pretreated metastatic colorectal cancer (mCRC) |
| Dec 12, 2026 | Imsidolimab | Vanda Pharmaceuticals Inc. (VNDA) | Generalized Pustular Psoriasis |
| Dec 17, 2026 | Relacorilant | Corcept Therapeutics Incorporated (CORT) | Hypercortisolism (Cushing's syndrome) |
| Dec 18, 2026 | Giredestrant + everolimus | Genentech, Inc. (Roche) (RHHBY) | ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen |
| Dec 19, 2026 | Imlifidase | Hansa Biopharma AB (HNSA) | Kidney transplant desensitization (highly sensitized patients) |
| Dec 22, 2026 | Lorundrostat | Mineralys Therapeutics, Inc. (MLYS) | Hypertension |
| Dec 23, 2026 | Anitocabtagene autoleucel (anito-cel) | Arcellx, Inc. (ACLX) | 4th-line relapsed/refractory multiple myeloma |
| Dec 27, 2026 | Relutrigine | Praxis Precision Medicines, Inc. (PRAX) | SCN2A/SCN8A developmental & epileptic encephalopathies |
| Dec 30, 2026 | bezuclastinib | Cogent Biosciences, Inc. (COGT) | Non-advanced systemic mastocytosis (NonAdvSM) |
| Jan 6, 2027 | ANKTIVA (nogapendekin alfa inbakicept-pmln) + BCG | ImmunityBio, Inc. (IBRX) | BCG-unresponsive NMIBC with papillary disease (no CIS) |
| Jan 20, 2027 | Foundayo (orforglipron) | Eli Lilly and Company (LLY) | Chronic weight management in adults with obesity or overweight |
| Jan 21, 2027 | Zeleciment rostudirsen (z-rostudirsen, DYNE-251) | Dyne Therapeutics, Inc. (DYN) | Duchenne muscular dystrophy in individuals amenable to exon 51 skipping |
| Jan 29, 2027 | Ulixacaltamide | Praxis Precision Medicines, Inc. (PRAX) | Essential tremor |
| Jan 30, 2027 | Joenja | Pharming Group N.V. (PHAR) | — |
| Feb 27, 2027 | Zipalertinib | Cullinan Therapeutics, Inc. (CGEM) | NSCLC with EGFR exon 20 insertion (post-platinum) |
| Feb 28, 2027 | QTORIN | PALVELLA THERAPEUTICS, INC. (PVLA) | — |
| Mar 10, 2027 | Priority | Intellia Therapeutics, Inc. (NTLA) | — |
| Mar 16, 2027 | Resubmission | Aquestive Therapeutics, Inc. (AQST) | — |
| Apr 14, 2027 | ozekibart (INBRX-109) | Inhibrx Biosciences, Inc. (INBX) | Unresectable/metastatic conventional chondrosarcoma |
| May 1, 2027 | ifezuntirgene | uniQure N.V. (QURE) | — |
| May 8, 2027 | planned | BridgeBio Pharma, Inc. (BBIO) | — |
| Aug 27, 2027 | Technology | Rafael Holdings, Inc. (RFL) | — |
Browse by month
Upcoming
November 2026
14 decisions
December 2026
9 decisions
January 2027
5 decisions
February 2027
2 decisions
March 2027
2 decisions
April 2027
1 decision
May 2027
2 decisions
August 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.