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...
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.
