About the PDUFA Calendar

A free, live biotech catalyst calendar — PDUFA dates, AdCom meetings, Phase 3 trial readouts, conference schedules, and earnings. Built for retail biotech investors who track FDA catalysts without a Bloomberg terminal.

What This Tool Tracks

The calendar aggregates every major FDA catalyst in one place:

• PDUFA Dates — FDA target action dates for NDA and BLA submissions
• AdCom Meetings — FDA Advisory Committee votes with public dockets
• Phase 3 Trial Readouts — Pivotal data releases that move stocks
• Conferences — ASCO, ASH, ESMO, and other scientific meetings with major presentations
• Earnings — Quarterly calls where pipeline updates typically land

Each entry includes urgency color-coding (overdue / today / this week / this month / upcoming), designation badges (Breakthrough Therapy, Priority Review, Fast Track, Orphan, Rare Pediatric), and where applicable, a Probability of Approval (PoA) score based on historical FDA approval rates.

Who Built This

This tool was built and is maintained by Dan Sfera — a clinical trials veteran with 20+ years of experience in site management, trial design, and FDA interactions. Dan also runs a Substack newsletter with 10,000+ subscribers covering biotech investing, clinical trial analysis, and FDA catalyst tracking.

This tracker was built because existing tools are either paywalled, cluttered with noise, or don't give investors a clear probability estimate with real clinical context. Learn more about Dan →

What is a PDUFA Date?

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:

• Standard review applications within 10 months of filing
• Priority review applications within 6 months of filing

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).

How Probability of Approval (PoA) Works

The baseline PoA scores shown on this site are Bayesian base rates derived from historical FDA approval data:

• NDA/BLA (standard): 92% historical approval rate at submission stage
• NDA/BLA (priority review): ~90% (slightly lower because priority drugs often have less mature data)
• Phase III data: 25–58% depending on indication
• Phase II data: 28–33%
• Phase I data: 70–76% (high because most IND failures never reach FDA review)

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.

Data Sources

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).

Disclaimer