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.
FDA approves an expanded use for Amgens Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with lymphoblastic leukem...
FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.
