PDUFA Calendar by Month
Browse FDA decisions and biotech catalysts organized by month
31
PDUFA decisions
203
Phase 3 readouts
0
AdCom meetings
19
NDA / BLA filings
Biotech catalysts tracked in the next 6 months — updated daily, each date confidence-rated.
Key upcoming PDUFA decisions
Upcoming Months
September 2026Current
245 catalysts
October 2026
121 catalysts
November 2026
92 catalysts
December 2026
253 catalysts
January 2027
121 catalysts
February 2027
80 catalysts
March 2027
107 catalysts
April 2027
84 catalysts
May 2027
85 catalysts
June 2027
135 catalysts
July 2027
102 catalysts
August 2027
100 catalysts
September 2027
57 catalysts
Past Months
About the PDUFA Calendar
PDUFA (Prescription Drug User Fee Act) dates are FDA's target dates for completing their review of new drug applications. These dates are critical for biotech investors as FDA decisions often lead to significant stock price movements.
Our monthly PDUFA calendar helps you track:
- PDUFA dates - FDA target action dates for drug approvals
- Clinical trial results - Phase 1, 2, and 3 trial readouts
- Advisory committee meetings - FDA panel reviews
- SEC filings - Important regulatory filings
This page browses PDUFA decisions by month. For the definition, an FAQ and every upcoming decision in one list, see PDUFA Dates — what a PDUFA is & all upcoming FDA decisions. Or learn how the FDA approval process works.