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FDA catalyst basics
Plain-English, sourced explainers for biotech catalyst investors — no hype, no predictions.
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…
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…