Resmetirom (Rezdiffra): FDA Approval, Trial Data, Pipeline
Resmetirom is the first FDA-approved MASH drug, approved March 2024. See MAESTRO-NASH resolution rates, dosing, and what the confirmatory trial means next.
Resmetirom: Regulatory History
3 source-based articles maintained by the HealthRX.com Editorial Team.
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May 26, 2026latest review
Resmetirom: Regulatory History library
Showing 3 of 3 clinical reviews.
Rezdiffra (Resmetirom) Legal and Patent Challenges
A clinical and regulatory deep-dive into Rezdiffra (resmetirom) covering its accelerated FDA approval, patent portfolio, label specifications, post-market commitments, and the legal disputes shaping its commercial future.
Rezdiffra Prescribing Information (March 2024 FDA Label)
FDA approved resmetirom March 14, 2024 for MASH with F2-F3 fibrosis. Dosing is 80mg or 100mg daily; not legally compoundable since no shortage or generic exists.