An FDA inspection of a Global Calcium manufacturing facility in Hosur, India leads to a six-observation Form FDA-483 that cites significant GMP violat...
Federal Register notice: FDA determines that Exela Pharma Sciences fentanyl citrate injections, equivalent to 2.5mg/50mL and 5mg/100mL (EQ 0.05 mg bas...
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...
Federal Register notice: FDA announces a 10/30 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on patient-cen...
