HHS secretary Xavier Becerra announces that FDA commissioner Robert Califf will be heading soon to India to meet with Indian regulatory and drug indus...
Federal Register notice: FDA determines that Accord Healthcares bortezomib solution was not withdrawn due to safety or effectiveness reasons.
Federal Register notice: FDA denies a request for a hearing and permanently debars David Roy Winne from providing services related to an approved or p...
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.
