Madrigal Pharmaceuticals Initiates Rolling Submission of New Drug Application for Resmetirom to FDA for NASH Treatment
Madrigal Pharmaceuticals, Inc. has announced the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of its drug resmetirom for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company expects to complete the full submission of the NDA in July 2023.   Resmetirom was granted Breakthrough Therap..