[ Price : $8.95]
FDA warns Chinas Anhui Hanbon Daily Chemical Co. about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA extends by 90 days its review of a Regenxbios BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for ...[ Price : $8.95]
FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the ...[ Price : $8.95]
FDA places a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis.[ Price : $8.95]
Viking Therapeutics reports mixed data from a Phase 2 study for its oral obesity drug VK2735, with patients losing up to 12.2% of ...[ Price : $8.95]
FDA publishes a guidance with recommendations on the information to be in a predetermined change control plan in a marketing submi...[ Price : $8.95]
FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restriction...[ Price : $8.95]
An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosami...