Novo Nordisk, Wegovy and FDA
Digest more
Wegovy is now approved by the FDA to treat metabolic-associated steatohepatitis in adults with moderate-to-advanced fibrosis but without cirrhosis.
1d
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).
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 for Wegovy for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis in adults.