Getinge and its subsidiary Maquet Cardiovascular recall the VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the p...
Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they told the agency that the drug products were no longer ...
FDA proposes to deny a Vanda NDA for tradipitant and offers the company an opportunity to seek a commissioners hearing on the denial.
FDA warns Integra Lifesciences about Quality System Regulation violations in the manufacturing of neurological and neurosurgical medical devices at th...
FDA warns Marlborough, MA-based Hologic about Quality System and Medical Device Reporting violations in its production of implantable radiographic mar...
Federal Register notice: FDA issues Novo Nordisk a priority review voucher for gaining approval for its hemophilia drug Alhemo (concizumab-mtci) last ...
Federal Register notice: FDA withdraws the approval of 12 NDAs from multiple applicants because they are no longer marketed.
The HHS Inspector General raises concerns about three of 24 drugs approved through the FDA accelerated approval pathway.
