Historical FDA decisions
How FDA decided on new drugs at their first review, with a link to each FDA letter.
Point-in-time replay: see any drug as HealthTrade had it recorded on a past date.
These are FDA’s first-review decisions on new drugs (novel NDAs and new BLAs) since 2020, taken from FDA records: approvals from Drugs@FDA and complete response letters from openFDA.
A complete response letter means FDA did not approve the application at that review. Resubmissions aren’t listed, and a letter appears here only once FDA has later approved the drug.
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Data provided by the U.S. Food and Drug Administration.
Price moves around FDA decisions
The last close before each decision and the first trading day after it, for the company's ticker, with that day's volume against its 20-day average, as recorded.
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