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 ...
Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from being added to FDAs n...
Three Hogan Lovells attorneys analyze the new FDA medical device inspection compliance program and caution manufacturers to begin working on the signi...
Three drug trade associations give FDA their perspectives on increasing access to nonprescription drugs.
FDA warns Indias Cohance Lifesciences about CGMP violations in its production of drugs at one of its manufacturing sites.
President Trump signs a government spending bill that officially reinstates FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA classifies Abbott Diabetes Cares recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I...
FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing of a continuous glucose meter.
