Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product
USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD).
USFDA has approved Idorsia’s new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for
FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic
Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment
Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy
