pdufa.bio
Live · private beta · 2026
The biotech FDA-catalyst tape.
Facts, not advice.
Every upcoming FDA decision (PDUFA) on one screen, with the facts to weigh it — live price & options, run-up history, cohort base rates, registry monitoring, and a source-verified decision archive. On the web and as an installable app.
Upcoming FDA decision (PDUFA) calendar — 2026 · live price, options & run-up history
A LOOK INSIDE — REAL UPCOMING FDA DECISIONS · FREE
◉ Live options & expected move
Real ATM-straddle implied move vs the historical move for similar events — premium context, never a trade call.
◷ T-120 run-up history
See how each name traded into its decision: every swing high and sell-off, by market-cap tier.
▦ Cohort base rates
Historical approval & move statistics by cap tier (694 PDUFAs) — labeled as history, not predictions for any one drug.
⚠ Silent-Shift registry monitor
We watch ClinicalTrials.gov for quietly-changed trial dates and flag them with a verified timestamp.
✓ Verified decision archive
Past CRLs with the reason and a primary-source link; approvals are source-linked as we verify them.
↻ Auto-refreshing, ~5×/day
Prices, options and registry status stay fresh — on every device, installable to your home screen.
EXPLORE — FREE, NO LOGIN
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Not affiliated with or endorsed by the FDA. pdufa.bio is an independent service and is not affiliated with, endorsed by, or officially connected to the U.S. Food and Drug Administration. "FDA," "PDUFA," and all company, drug, and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational only — not investment advice. pdufa.bio provides data and historical statistics; it does not recommend trades, size positions, or estimate the approval probability of any individual drug. Markets are risky; verify every date and outcome against primary sources before acting.