FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.
The Justice Department says Glenmark Pharmaceuticals, a generic drug manufacturer in Mahwah, NJ, will pay $25 million to resolve civil claims involvin...
Breas Medical recalls (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing identified the potential for a short-...
Eli Lilly says data from two Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes showed non-inferiorit...
An Associated Press analysis says FDA is overdue on some 2,000 drug company facilities that havent been inspected since before the Covid-19 pandemic.
FDA asks its Antimicrobial Drugs Advisory Committee whether an Iterum NDA for sulopenem etzadroxil/probenecid to treat some uncomplicated urinary trac...
Biosimilars Forum asks FDA for further information and clarification on certain areas of the agencys recent draft guidance entitled Purpose and Conten...
FDA publishes a revised guidance on controlling nitrosamine impurities in human drugs.
