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...
FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated steatohepatitis clinical...
FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Pro...
FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.
FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hearing system.