Free, live FDA drug approval calendar — built for retail biotech investors who don't have time to dig through press releases.
Dan Sfera has spent over 20 years working in clinical trials — from site management to trial design to FDA interactions. He runs a Substack newsletter (@dansfera1) with 10,000+ subscribers focused on biotech investing, clinical trial analysis, and FDA catalyst tracking.
This tracker was built because the existing tools are either behind paywalls, cluttered with noise, or don't give investors a clear probability estimate with real clinical context.
A PDUFA date (Prescription Drug User Fee Act date) is the FDA's self-imposed deadline to complete its review of a New Drug Application (NDA) or Biologics License Application (BLA). Under the PDUFA agreement, the FDA commits to reviewing:
The PDUFA date is the most-watched catalyst in biotech investing. On or before this date, the FDA will typically: approve the drug, issue a Complete Response Letter (CRL) rejecting it, or request more time (extension).
The baseline PoA scores shown on this site are Bayesian base rates derived from historical FDA approval data:
Dynamic sentiment-adjusted PoA is coming soon — powered by xAI/Grok API, analyzing real-time social sentiment from biotech investor communities to adjust the baseline upward or downward based on current market expectations.
PDUFA dates are publicly available from FDA's official calendar, company press releases, and verified by cross-referencing multiple public sources including BiopharmaWatch, RTTNews FDA Calendar, and company SEC filings.
This site is updated regularly. New PDUFA dates are added as companies announce FDA filing acceptances. If you notice a missing or incorrect date, reach out on X (@dansfera).