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CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on...[ Price : $8.95]
Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially invol...[ Price : $8.95]
FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract ma...[ Price : $8.95]
FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program...[ Price : $8.95]
FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated stea...[ Price : $8.95]
FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Prod...[ Price : $8.95]
FDA advises the companies manufacturing RSV therapies for infants that the agency is taking a new look at the therapies safety.[ Price : $8.95]
FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of the Esteem II implantable hea...