What is Accelerated Approval?

Approval based on a surrogate endpoint, with confirmatory trials required afterward.

Accelerated Approval lets serious-condition drugs reach market on biomarker evidence. The catch: confirmatory trials are required post-approval, and the FDA has grown aggressive about withdrawing drugs whose confirmatory data disappoints.

A failed confirmatory trial years after launch can still crater a stock — these withdrawal proposals appear in our FDA events feed.

See it live: the catalyst calendar · status-change feed