Glossary

What is a PDUFA date?

The FDA's target date for deciding on a drug application — the single most-watched date in biotech.

PDUFA stands for the Prescription Drug User Fee Act. When the FDA accepts a New Drug Application (NDA) or Biologics License Application (BLA), it commits to a target action date, typically 6–10 months out (10 months standard review, 6 months priority).

A PDUFA date is not a guarantee of approval — the FDA can approve, issue a Complete Response Letter, or (rarely) delay — but it is the calendar anchor every biotech trader plans around, because decisions routinely move the stock 20–80% in a day.

Companies disclose PDUFA dates in 8-K filings and press releases; there is no structured free source, which is why our calendar extracts them from the filings themselves and links the exact sentence.

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