In September, the FDA accepted the company's marketing application for resmetirom, granting it the agency's priority review for NASH with liver fibrosis, with a decision expected on or before Mar. 14.
Its lead candidate resmetirom met its primary and secondary objectives in the trial, which involved patients with non-alcoholic fatty liver disease (NAFLD) including some with presumed NASH ...
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) has become the first drug to be approved by the US Food and Drug Administration (FDA) as a treatment for noncirrhotic nonalcoholic ...
The Massachusetts company has reported the results of the phase 3 MAESTRO-NASH trial of resmetirom – a once daily, oral, thyroid hormone receptor (THR) β-selective agonist – showing that it ...