A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of ...
FDA warns Clarksville, TN-based Insightra Medical about multiple violations in its production of intra-aortic balloon pump catheter kits with specific...
A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concerns about the safety o...
FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients livin...
FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.
Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...
FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were included in a Cefazolin...
FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.
