Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

FDA approves Resmetirom for fatty liver

FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic

Qvents
March 16, 2024

USFDA approves Orchids innovation drug E

Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment

Qvents
February 26, 2024

USFDA approves Santhera’s New Molecula

Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy

Qvents
October 30, 2023