pharmaphorum December 9, 2025
Phil Taylor

The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with metabolic dysfunction-associated steatohepatitis (MASH) to help measure disease activity.

Called AIM-NASH, it is a cloud-based tool designed to help pathologists score liver biopsy components on measures such as fat infiltration (steatosis), inflammation (hepatocellular ballooning and lobular inflammation), and scarring (fibrosis), which are all features of MASH.

FDA qualification means it can now be used in any drug development programme for a MASH treatment and support regulatory filings of new therapies. As it stands, there are two drugs approved for MASH – Madrigal Pharma’s THR β-selective agonist Rezdiffra (resmetirom) and Novo Nordisk’s GLP-1 agonist Wegovy (semaglutide) – and dozens more coming through the...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Technology
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