Every FDA decision, with the facts to weigh it.

It is the deadline the FDA sets for itself to decide whether to approve a new medicine. When a drug company applies, it pays a fee, and in return the FDA commits to answering by a specific day. That day is the PDUFA date. The name comes from the Prescription Drug User Fee Act, the 1992 law that set the system up.

One of two things. The FDA approves the drug, or it sends the company a Complete Response Letter, usually shortened to CRL, which is a rejection that lists what would need to be fixed. A CRL is not always permanent: companies often fix the problem and reapply. The FDA can also decide early, or miss its own deadline entirely, and it does not have to explain a delay.

Measured across 1,829 decisions since 2020, most of the movement happens in the months before the date rather than on it. The median stock rose 17.7% at its best point in the 120 trading days before the decision, but was only 1.8% higher on the day before it. In other words the typical run-up was largely given back before the answer arrived. That is what happened historically, across the whole group. It is not a prediction about any one stock.

It is a panel of outside experts the FDA can convene to discuss a hard application in public. They vote, but the vote is advice. The FDA usually follows it and is not required to. A negative vote is a serious signal, not a verdict.

It is the moment a company reports results from a clinical trial. Readouts happen years before an FDA decision and are often the bigger share-price event, because they are the first time anyone outside the trial learns whether the drug worked.

FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with prices measured from daily closing data. Every date and outcome on this site links to the document it came from. Where we have inferred something rather than sourced it, the page says so.