Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for
Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune
The scientific community mourns the loss of Dr.Akiro Endo, whose death was announced by the
Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer
FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD)
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
FDA has approved Novartis’ Iptacopan (Fabhalta) for treatment of rare blood disease, Paroxysmal Nocturnal Hemoglobinuria
