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PDUFA Calendar

FDA Drug Approval Target Dates — Track upcoming PDUFA dates, NDA/BLA decisions, and position ahead of market-moving catalysts.

— Total Events

— This Month

— This Week

— NDA

— BLA

PDUFA dates are the single most important catalyst for biotech stocks. The FDA sets a target decision date (PDUFA date) when it accepts a New Drug Application (NDA) or Biologics License Application (BLA). On this date, the FDA announces: Approved, Complete Response Letter (CRL) meaning rejected/needs more data, or Delayed.

Historically, biotech stocks show a predictable "run-up" pattern of 10-30% in the 2-4 weeks before a PDUFA date as traders speculate on approval. After the decision, stocks can gap +50% on approval or drop -40% on CRL. Knowing these dates in advance is crucial for risk management.

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This week This month Upcoming Approved CRL / Delayed NDA = New Drug Application • BLA = Biologics License • sNDA/sBLA = Supplemental