FDA classifies Abbott Diabetes Cares recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I...
Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from being added to FDAs n...
Amgen rejects an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to concerns related to ...
FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as a potential first-li...
Former CDRH branch chief Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the pro...
A new GAO report finds FDAs regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reductio...
FDA sends AstraZeneca a complete response letter rejecting approval of its BLA for a subcutaneous formulation of Saphnelo (anifrolumab) for treating a...
FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infusion sets.
