CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.
FDA belatedly inspects Indias Glenmark Pharmaceuticals after a recent ProPublica investigative report found that the agency hadnt shifted any attentio...
FDA names former business consultant Jim Traficant as chief of staff where he will oversee and lead the agencys major initiatives.
Mineralys Therapeutics reports positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials assessing lorundrostat...
FDA clarifies its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a pre...
Dexcom says it received an FDA Warning Letter following inspections at the companys facilities in San Diego, CA and Mesa, AZ.
HHS offers its 80,000 federal employees, including FDA, up to a $25,000 buyout to retire or leave their government employment as part of new move to c...
FDA clears a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant for patients who have sensitivities to certain meta...
