FDA reverses its enforcement stance against Sarepta Therapeutics and Duchenne Muscular Dystrophy gene therapy Elevidys after determining the latest pa...
FDA clears a Stereotaxis 510(k) for its MAGiC Sweep catheter, a robotically navigated high-density electrophysiology mapping catheter for diagnosing a...
FDA issues an alert based on related to its ongoing investigation into the root causes of benzene contamination, calling on drug makers to evaluate th...
Ethicon Endo-Surgery recalls (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the products inadvertent lockout during ...
FDA commissioner Marty Makary defends CBER director Vinay Prasad from recent criticism by Trump confidant Laura Loomer.
FDA extends by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating menopause-rel...
FDA and American Society of Clinical Oncology researchers urge drug makers to abandon outdated drug dosing strategies that are potentially putting can...
Edwards Lifesciences recalls (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in whic...
