Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...
Takeda says data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) in Dravet syndrome and Lennox-Gastaut syndrome patients failed to meet t...
FDA posts a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.
Federal Register notice: FDA announces a proposed administrative order to require a warning on Over-the-Counter Internal Analgesic, Antipyretic, and A...
Teleflex and subsidiary Arrow International recall (Class 1) the Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic...
Getinge recalls (Class 1) its Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration or corrosion within the vaporizer.
Novavax files an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.
FDA posts a final guidance entitled Diabetic Foot Infections (DFI): Developing Drugs for Treatment.
