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.