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No PDUFA date is tracked for September 2028 yet. Each row shows the drug, company, indication, status and how firm the date is.
No catalysts scheduled
There are no FDA decisions or catalyst events scheduled for September 2028.
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PDUFA dates September 2028: questions
- How many FDA decisions (PDUFA dates) are in September 2028?
- No PDUFA date is tracked for September 2028 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 September 2028
This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for September 2028. 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.