About pdufa.bio
An independent, free record of what the FDA is about to decide — and what happened to the stock the last few thousand times it decided something.
What this is.
A public calendar of upcoming FDA decisions (PDUFA dates), advisory committee meetings, clinical readouts and medical conference presentations — plus original research on how biotech stocks have actually traded around those events. The calendar is free, requires no login, and the
API is free for the same data you can see on the page.
What we refuse to do
This is the part most sites in this category will not write down.
- No approval probabilities. We will not tell you a drug has a 78% chance of approval. We have the models to produce that number. We do not publish it, because a single figure invites you to act on it and the honest uncertainty around it is enormous. See why.
- No win rates, no entry or exit signals, no position sizing. Historical statistics only: median, interquartile range, and the sample size next to every one.
- No number we cannot defend against the raw data. When a statistic is punchy but misleading, we publish the duller true one. We have turned down our own best headline on exactly these grounds.
- No silent edits. Every material change to a published figure is logged, with its cause, on the corrections page — including corrections we rejected.
Where the data comes from
PDUFA dates, advisory committees and conference presentations are sourced from primary documents: company filings on SEC EDGAR (8-K, 10-K, press-release exhibits), FDA announcements, and company investor relations releases. Every catalyst carries a link to the document it came from. Prices are daily closes. Market-cap tiers are computed as of the event date, not today — using today's would be a look-ahead error, and we made exactly that mistake once.
We do not republish licensed third-party datasets. Our research pages are built from our own data and released under CC BY 4.0 — use them with attribution.
Limitations we want you to know
Selection bias. Our conference dataset only sees companies that filed about a presentation. A company that presents quietly is invisible to us. We do not know what fraction of real presenters we capture, and we will not claim a coverage number we have not measured.
Regime, not law. The same event type produced +17% in one year and −3% in another. Nothing here is a constant.
Self-selection. Companies choose when to present and what to announce. Any apparent “effect” is contaminated by that, and we make no causal claim.
Who runs it
pdufa.bio is run by a single independent operator — not a fund, not a broker, not a data vendor, and not affiliated with the FDA or any medical society. There is no advertising on this site, and no one pays to appear on the calendar.
Contact: data@pdufa.bio — corrections, dataset requests, and press. We answer corrections first.
This is not investment advice, and we are not your advisor.
Everything here is historical fact and descriptive statistics. It is not a forecast for any company or event, it is not a recommendation, and past price behaviour does not predict future outcomes. If you are making financial decisions, talk to someone who is licensed to advise you. We are not.
Not affiliated with or endorsed by the FDA or any medical society. pdufa.bio is an independent service. Informational and educational only — not investment advice. These are historical statistics; they are not a forecast for any company or event, they are not a trading strategy, and they carry no entry, exit or position-sizing guidance. Past price behaviour does not predict future outcomes. © 2026 pdufa.bio