Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with Duchenne muscular d...
FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE.
Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.
FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectivity.
FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProSense cryoblation sys...
FDA grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.
FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment with several targeted ...
The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change control plans.
