Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two cl...
FDA warns six companies that they are marketing unapproved fat-dissolving drugs.
FDA accepts a Sydnexis NDA for SYD-101 (topical low-dose atropine) for treating progression of pediatric myopia.dr
FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.
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...