Accelerated Approval Withdrawal Offers Hints On New FDA Approach

By Luke Zarzecki / March 4, 2024 at 1:59 PM

FDA’s decision to rescind accelerated approval of Oncopeptides AB’s multiple myeloma drug Pepaxto could offer a glimpse of potential policies to be included in a draft guidance due in June on accelerated approval rescissions, and poses unclear implications for other drugs as rare disease stakeholders call for the agency to step up use of the accelerated approval pathway.


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