CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription marketing status and AN...
CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on single-arm studies ...
Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially involving off-label presc...
FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract manufacturer.
FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program, permitting new U.S...
A biosimilars scholar files a citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements.
FDA approves Gamida Cells Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia.
FDA postpones a promised safety review of the abortion drug mifepristone and is now not likely to be released until after the 2026 midterm elections.
