Posted by Michael Wonder on 01 Jul 2023
Madrigal Pharmaceuticals announces rolling submission of new drug application to US FDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis
30 June 2023 - Madrigal expects to complete full submission of the new drug application in July 2023.
Madrigal Pharmaceuticals initiated a rolling submission of a new drug application (NDA) to the US FDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis.
Madrigal has submitted the majority of the NDA to the FDA and plans to submit the remaining components in July 2023. The company will request a priority review of the NDA.
