Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has approved Checkpoint Therapeutics Cosibelimab-ipdl (Unloxcyt) for treatment of skin cancer CSCC (metastatic cutaneous squamous
USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the
FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for
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
Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to
