The FDA isn’t afraid to yank a disappointing drug

Stat News

26 February 2024 - The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, the agency’s first exercise of a new authority that allows regulators to more quickly withdraw drugs that have not lived up to their promise.

The decision concludes a seven month process that began after Oncopeptides’ drug, which won accelerated approval in 2021, failed in a Phase 3 study meant to confirm its observed benefits.

Read Stat News article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Cancer , Medicine , US , Regulation