FDA issues a finalized question-and-answer guidance on submitting field alert reports.
FDA grants AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA methylation detection...
Mintz attorneys say an FDA draft medical device remanufacturing guidance fails to give information that entities need to determine if their activities...
FDA grants Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating adult patients with pr...
FDA clears a Zoll Medical 510(k) for its TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator for managing patients with ...
FDA places a clinical hold on a Magenta Therapeutics Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia and myelodysplastic ...
Vero Biotech recalls its Genosyl DS; Nitric Oxide Delivery System due to a software issue that leads to errors in gas delivery.
FDA acting commissioner Janet Woodcock discusses new agency plans to better secure the medical device supply chain.