Blog Tag
3 articles tagged with Accelerated Approval. The newest post is from Feb 22, 2026.
A surrogate endpoint is a clinical trial endpoint that stands in for a direct measure of how a patient feels, functions, or survives. Instead of waiting for a long-term clinical outcome, researchers use a surrogate that is reasonably expected to predict benefit. In biotech, surrogate endpoints are especially important because they can make development and approval faster in settings where waiting for the final outcome would take too long.
A post-marketing study is a study a company conducts after a drug has been approved and marketed. The purpose may be to confirm benefit, collect longer-term safety data, study a new population, or satisfy an FDA requirement tied to an approval pathway such as accelerated approval. In biotech, post-marketing studies matter because approval is often not the end of the regulatory story.
Accelerated approval is an FDA pathway that allows certain drugs for serious conditions to be approved based on a surrogate endpoint or another intermediate clinical measure that is reasonably likely to predict benefit. In biotech, the pathway matters because it can bring promising therapies to patients sooner when waiting for traditional long-term outcomes would be impractical.
