FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.
FDA warns Chinas Anhui Hanbon Daily Chemical Co. about CGMP violations in its production of finished drugs.
FDA extends by 90 days its review of a Regenxbios BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for Hunter syndrome.
FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the drugs effectiveness ...
FDA places a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis.
Viking Therapeutics reports mixed data from a Phase 2 study for its oral obesity drug VK2735, with patients losing up to 12.2% of body weight over 13 ...
FDA publishes a guidance with recommendations on the information to be in a predetermined change control plan in a marketing submission for a device t...
FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restrictions on ANDAs citing Fi...
