Federal Register notice: FDA announces that it issued Mirum Pharmaceuticals a priority review voucher for its approved rare pediatric disease product ...
Novartis says its Leqvio successfully lowered LDL cholesterol as a monotherapy in the Phase 3 V-MONO trial.
FDA warns three companies illegally marketing CPAP cleaning/sanitizing devices in the U.S.
FDA accepts for priority review a Soleno Therapeutics NDA for DCCR (diazoxide choline) for treating Prader-Willi syndrome (PWS) in individuals aged fo...
FDA accepts for priority review a SpringWorks Therapeutics NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adult pat...
FDA warns Durham, NC-based CARsgen Therapeutics about CGMP violations in its production of investigational drugs and biologics used in a Phase 2 trial...
Federal Register notice: FDA announces the issuance of an emergency use authorization for Octapharmas freeze-dried plasma product, octaplasLG Powder, ...
FDA warns Watertown, MA-based EyePoint Pharmaceuticals about CGMP violations in its production of finished drugs.
