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 ...
FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program, permitting new U.S...
Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially involving off-label presc...
Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles,...
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 warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract manufacturer.
FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.
