FDA clears an Anika Therapeutics 510(k) for the Integrity Implant System, intended for use in augmenting an injured tendon to promote healing in rotat...
FDA approves a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age and older with Chap...
Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating certain adults with ...
FDA updates its list of ultraviolet wand products that may present a potential risk of injury.
FDA clears a GE HealthCare 510(k) for its Portrait Mobile wireless and wearable monitoring device.
FDA approves Ipsens Sohonos as the first treatment for adults and some pediatric patients with fibrodysplasia ossificans progressiva.
FDA says the Datascope/Maquet/Getinge recall of Cardiosave balloon pumps is Class 1.
FDA grants BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms ...