Federal Register notice: FDA corrects an 8/14 notice that announced a modification to the organizational structure of CDRHs Office of Strategic Partne...
The U.S. Justice Department fines Teva Pharmaceuticals USA and Glenmark Pharmaceuticals over $300 million in deferred prosecution agreements involving...
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Federal Register notice: FDA determines that Accord Healthcares bortezomib solution was not withdrawn due to safety or effectiveness reasons.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 ...
