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 ...
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FDA approves Madrigal’s Rezdiffra as the first NASH therapyMadrigal 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 ...
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