PDUFA Calendar by Month
Browse FDA decisions and biotech catalysts organized by month
Biotech catalysts tracked in the next 6 months — updated daily, each date confidence-rated.
Key upcoming PDUFA decisions
Upcoming Months
Past decisions
Resolved FDA decisions and trial readouts, with the outcome and stock move, are on the catalyst outcomes page.
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.