novo nordisk, MASH and Wegovy
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Wegovy is now approved by the FDA to treat metabolic-associated steatohepatitis in adults with moderate-to-advanced fibrosis but without cirrhosis.
The Food and Drug Administration approved the weight loss drug Wegovy to treat an increasingly prevalent liver disease on Friday. Roughly 15 million people — six percent of adults in the United States — have metabolic dysfunction-associated steatohepatitis, known as MASH. Rates of the disease are rising.
The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according to analysts at BMO Capital Markets.
The FDA has granted accelerated approval to semaglutide (Wegovy; Novo Nordisk) injection 2.4 mg for the treatment of adults with metabolic dysfunction–associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, making it the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for this indication. 1
Novo Nordisk's GLP-1 drugs have been under considerable competitive pressure in the last few months, so the company will be celebrating a first-in-class approval from the FDA for Wegovy in metabolic dysfunction-associated steatohepatitis (MASH).
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Pharmaceutical Technology on MSNWegovy becomes first GLP-1RA to gain FDA MASH approval
Novo Nordisk's Wegovy has received accelerated approval for use in patients with metabolic dysfunction-associated steatohepatitis (MASH).
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MedPage Today on MSNSemaglutide Gets FDA Greenlight for MASH
The glucagon-like peptide-1 (GLP-1) receptor agonist gained accelerated approval for patients with MASH and moderate to advanced liver fibrosis but no cirrhosis, to be given as a once-weekly, 2.4-mg subcutaneous injection alongside diet and exercise, drugmaker Novo Nordisk noted.
A Florence + The Machine album on Halloween just feels right. On Tuesday the band announced their new record Everybody Scream, debuting October 31. It was appropriately preceded by a teaser video (below),