Posted by Michael Wonder on 13 Sep 2023
Madrigal Pharmaceuticals announces NDA acceptance and priority review of the new drug application for resmetirom for the treatment of NASH with liver fibrosis
13 September 2023 - Madrigal Pharmaceuticals today announced that the US FDA has accepted for review its new drug application for resmetirom for the treatment of adult patients with NASH with liver fibrosis.
The FDA has granted priority review and assigned a Prescription Drug User Fee Act date for resmetirom of 14 March 2024, the target date by which the FDA intends to complete its review and take action on the new drug application.
