PDUFA Calendar by Month
Browse FDA decisions and biotech catalysts organized by month
33
PDUFA decisions
229
Phase 3 readouts
1
AdCom meetings
14
NDA / BLA filings
Biotech catalysts tracked in the next 6 months — updated daily, each date confidence-rated.
Key upcoming PDUFA decisions
Ziftomenib — Kura Oncology, Inc. (KURA)Oct 22, 2026TAK-771 — TAKEDA PHARMACEUTICAL CO LTD (TAK)Nov 10, 2026Povetacicept — Vertex Pharmaceuticals Incorporated (VRTX)Nov 30, 2026CAM2029 — Camurus AB (CAMX.ST)Dec 18, 2026Lorundrostat — Mineralys Therapeutics, Inc. (MLYS)Dec 31, 2026Taletrectinib — Nuvation Bio Inc. (NUVB)Jan 4, 2027
Upcoming Months
July 2026Current
294 catalysts
August 2026
710 catalysts
September 2026
136 catalysts
October 2026
98 catalysts
November 2026
94 catalysts
December 2026
217 catalysts
January 2027
93 catalysts
February 2027
82 catalysts
March 2027
87 catalysts
April 2027
74 catalysts
May 2027
116 catalysts
June 2027
135 catalysts
July 2027
66 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.