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Novo's Wegovy picks up 3rd indication with key FDA approval in the liver disease MASH
With a new endorsement from the FDA, Novo Nordisk’s Wegovy has picked up its third indication and become the second drug approved in a severe form of fatty liver disease. | The FDA has signed off on an accelerated approval for Novo Nordisk's Wegovy to treat certain adults with metabolic-associated steatohepatitis.
Wegovy is now approved by the FDA to treat metabolic-associated steatohepatitis in adults with moderate-to-advanced fibrosis ...
The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according ...
The approval was based on Part 1 (72 week data) of the randomized, double-blind, placebo-controlled phase 3 ESSENCE trial.
GlobalData on MSN22h
Wegovy becomes first GLP-1RA to gain FDA MASH approval
The drug received accelerated approval for use in patients with metabolic dysfunction-associated steatohepatitis (MASH).
The FDA has approved Wegovy for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis ...
Health and Me on MSN7h
Wegovy Approved For MASH Treatment With Fibrosis But No Cirrhosis
FDA has approved Novo Nordisk's Wegovy, one-weekly 2.4 mg semaglutide injection for treating metabolic-associated ...
The glucagon-like peptide-1 (GLP-1) receptor agonist gained accelerated approval for patients with MASH and moderate to ...
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