PDUFA Calendar 2026: Upcoming FDA Drug Approval Dates

Track every upcoming FDA PDUFA target action date with ODIN AI approval probability scores. The interactive calendar below includes 40+ confirmed 2026 PDUFA dates, 194 clinical trial readouts, and 141 earnings events. Filter by therapeutic area, ODIN tier, or date range. See the full 2026 calendar analysis →

Recent FDA Decisions (Resolved)

DateTickerDrugIndicationOutcome
2026-01-12FBIOZYCUBO (copper histidinate)Menkes Disease✓ APPROVED
2026-02-09RGNXRGX-121MPS II✗ CRL
2026-02-20VNDABysanti (milsaperidone)Schizophrenia✓ APPROVED

Upcoming PDUFA Dates

DateTickerDrugIndicationTA
2026-02-25OTSKFINQOVI + VenetoclaxAcute Myeloid LeukemiaOncology
2026-02-24REGNDupixent (dupilumab)AFRS — APPROVED Feb 24Immunology
2026-02-28ASNDNavepegritideAchondroplasiaEndocrinology
2026-03-06BMYDeucravacitinib (Sotyktu)Psoriatic ArthritisImmunology
2026-03-20RYTMImcivreeHypothalamic ObesityEndocrinology
2026-03-24GSKLinerixibatCholestatic Pruritus (PBC)Hepatology
2026-03-25LLYOrforglipronType 2 DiabetesEndocrinology
2026-03-28RCKTKresladiLeukocyte Adhesion Deficiency-I (LAD-I)Gene Therapy
2026-03-29LNTHGa68-edotreotideGEP-NETs ImagingOncology
2026-04-05DNLITividenofusp alfaMPS-IIIA (Sanfilippo)Rare Disease
2026-05-15TVTXPivlicaftor PotentiatorCystic FibrosisPulmonology
2026-06-20ACLXCytisiniclineSmoking CessationCNS
2026-07-01KURATipifarnibHRAS-Mutant HNSCCOncology
2026-07-07VERAAtaciceptIgA NephropathyNephrology

Showing 14 of 40+ confirmed PDUFA events. Use the interactive calendar below to see all events with ODIN scores. Upgrade to Pro for full probability scores and alerts.

Frequently Asked Questions

How many PDUFA dates are scheduled for 2026?

As of February 2026, there are 40+ confirmed FDA PDUFA target action dates for 2026, spanning oncology, neurology, rare disease, immunology, and cardiovascular therapeutic areas.

What is the FDA's PDUFA date approval rate?

Approximately 67.7% of PDUFA decisions result in approval. ODIN TIER_1 predictions have a 93.6% approval rate. See track record →

Can the FDA act before the PDUFA date?

Yes — the FDA frequently acts early. VNDA's Bysanti was approved Feb 20, one day before its Feb 21 PDUFA date.

Featured PDUFA Catalysts — ODIN Scored

See all upcoming PDUFA dates 2026. Learn what a PDUFA date is. Understand how ODIN predicts FDA approvals.

Important: PDUFA.BIO is not the FDA. ODIN scores are ML model outputs, not financial advice. All investing carries risk. Read full disclaimer →

PDUFA.BIO
Tue Mar 3, 2026
12 this week

FDA PDUFA Calendar 2026 — Biotech Catalyst Dates

Complete calendar of upcoming FDA PDUFA dates, Phase 2/3 clinical trial readouts, and biotech earnings. Click any event for ODIN AI approval scoring. Tracking 50 PDUFAs, 186 readouts, and 27 earnings.

March 2026(45 events)

Sun
Mon
Tue
Wed
Thu
Fri
Sat
1
2
3TODAY
+3 more
4
+1 more
5
+2 more
6
7
8
9
10
11
+9 more
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
PDUFA
Readout
Earnings

PDUFA.BIO

FDA catalyst intelligence powered by the ODIN v1108 scoring engine. Trained on 2,200+ PDUFA decisions & 2,000+ phase readouts (2015–2026).

PLATFORM

DashboardCalendarScreenerRunup StrategyTrack RecordPaper TradeToolsPricing

LEARN

What Is a PDUFA Date?GlossaryResearchAbout ODINData SourcesPartnersAdvertiseAPIDisclaimer

PDUFA.BIO is the data-driven FDA PDUFA calendar and biotech catalyst calendar built for quantitative investors. Track upcoming PDUFA dates for 2026, FDA drug approval action dates, and biotech earnings dates in a unified, filterable calendar. Learn what a PDUFA date is and how the ODIN AI scoring engine generates FDA approval probability scores. Use the biotech catalyst screener to filter by ticker, therapeutic area, and ODIN tier. Explore the PDUFA runup strategy and verify ODIN's accuracy on the verified track record page. Browse our biotech glossary and catalyst research hub.

DISCLAIMER: PDUFA.BIO is not affiliated with, endorsed by, or connected to the U.S. Food & Drug Administration (FDA) or any government agency. The name "PDUFA" refers to the Prescription Drug User Fee Act and is used descriptively. This site does not provide financial, investment, legal, or medical advice. PDUFA.BIO is not a registered investment advisor, broker-dealer, or financial planner. Probability scores are generated by machine-learning models based on historical data and publicly available information. These scores are statistical estimates, not predictions or guarantees of FDA action or securities performance. Past approval rates do not guarantee future results.

RISK WARNING: Investing in biotechnology and pharmaceutical securities involves substantial risk, including the risk of total loss of capital. Binary catalyst events (such as PDUFA dates) can result in extreme price volatility. You should not invest money you cannot afford to lose. Always consult with a qualified financial advisor before making investment decisions. PDUFA.BIO, its operators, contributors, and affiliates accept no responsibility or liability for any losses arising from use of this site.

© 2026 PDUFA.BIO — All rights reserved.Market data via FMP · Social data via LunarCrush