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No PDUFA date is tracked for November 2027 yet. Each row shows the drug, company, indication, status and how firm the date is.
Week 1Nov 1 - Nov 7(10 catalysts)
- Q4 2027~QBGNETislelizumab Phase 3 Est. Readout (SMALLER)
- Q4 2027~QAZNDurvalumab Phase 3 Est. Readout (AVANZAR)
- Q4 2027~QAZNCapivasertib Phase 3 Est. Readout (CAPItello-292)
- Q4 2027~QOTSKFJNT-517 Phase 3 Est. Readout
- Q4 2027~QPFECombination 1 Phase 2 Est. Readout
- Q4 2027~QSNYChlamydia mRNA Vaccine Phase 2 Est. Readout
- Q4 2027~QAZNTozorakimab Phase 3 Est. Readout (TILIA)
- Q4 2027~QMRKMK-5684 Phase 2 Est. Readout
- Q4 2027~QGSKRis-Rez Phase 2 Est. Readout
- Q4 2027~QSNYrilzabrutinib Phase 3 Est. Readout (LUNA 4)
Week 2Nov 8 - Nov 14
No catalysts this week
Week 3Nov 15 - Nov 21
No catalysts this week
Week 4Nov 22 - Nov 28
No catalysts this week
Week 5Nov 29 - Dec 5
No catalysts this week
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PDUFA dates November 2027: questions
- How many FDA decisions (PDUFA dates) are in November 2027?
- No PDUFA date is tracked for November 2027 as of November 6, 2026.
- What is a PDUFA date?
- The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.
About PDUFA Dates in November 2027
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for November 2027. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).
Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.
Learn more about PDUFA dates or view the full biotech catalyst calendar.