European Commission grants conditional marketing authorization to Rezdiffra for MASH

Madrigal Pharmaceuticals/Rezdiffra

The European Commission granted conditional marketing authorization for Rezdiffra (resmetirom) for adults with noncirrhotic MASH and moderate-to-advanced liver fibrosis. The approval followed a positive recommendation from the EMA's Committee for Medicinal Products for Human Use (CHMP) in June 2025. Conditional authorization requires submission of further clinical data as a postapproval condition.