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FDA Approves First MASH Treatment Amid Rising Demand

10/18/2025

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Summary

Story summary

In March 2024, the U.S. Food and Drug Administration approved Madrigal Pharmaceuticals' Rezdiffra as the first therapy for MASH.
In August 2025, Novo Nordisk's Wegovy received a label expansion for MASH.
Approximately 22 million U.S. adults have MASH, with many lacking access to treatment.
GSK, Roche, and Novo Nordisk are pursuing combination therapies and acquiring promising candidates.
Phase 3 trials will be crucial to validate these investments.

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Story summary

In March 2024, the U.S. Food and Drug Administration approved Madrigal Pharmaceuticals' Rezdiffra as the first therapy for MASH.
In August 2025, Novo Nordisk's Wegovy received a label expansion for MASH.
Approximately 22 million U.S. adults have MASH, with many lacking access to treatment.
GSK, Roche, and Novo Nordisk are pursuing combination therapies and acquiring promising candidates.
Phase 3 trials will be crucial to validate these investments.