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Learn the FDA catalyst basics

Updated ·next FDA decision on the calendar
Plain-English, sourced explainers for biotech catalyst investors, no hype, no predictions.
Why we don't show an approval %: other sites print an “AI” 82%/99% on every drug. A single number is false precision for a binary FDA decision: here's what we show instead.
What is a PDUFA date?
A PDUFA date is the FDA's target deadline to decide on a drug application. Learn what it…
What is a Complete Response Letter (CRL)?
A Complete Response Letter (CRL) is the FDA's way of saying a drug is not approved as…
Why can't you compare two drugs' trial results?
Different patients, endpoints and eras make cross-trial comparison invalid. What the FDA actually weighs, and what can honestly be compared…
FDA Advisory Committee (AdCom) meetings
An FDA Advisory Committee (AdCom) is a panel of outside experts that votes on whether a…
Priority Review vs Standard Review
FDA priority review targets a ~6-month decision; standard review ~10 months. Learn what…
What happens to a stock on its PDUFA date?
How biotech stocks move on an FDA PDUFA decision: the reaction scales with company size…
What is FDA accelerated approval?
FDA accelerated approval lets a drug reach market based on a surrogate endpoint, with…
PDUFA vs BsUFA vs GDUFA
PDUFA covers brand drugs, BsUFA covers biosimilars, and GDUFA covers generics: each sets…