The FDA clearance sets Novo’s medicine up a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

With a new endorsement from the FDA, Novo Nordisk’s Wegovy has picked up its third indication and become the second drug ...

The approval makes Wegovy the only GLP-1 therapy cleared to treat adults with metabolic dysfunction-associated ...

Here's what investors need to know. On Friday, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had ...

Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s ...

The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according ...

Expanded approval of Wegovy was based on results from the Phase III ESSENCE trial (NCT04822181), which demonstrated ...

Novo Nordisk said on Friday the U.S. Food and Drug Administration has granted accelerated approval for its weight-loss drug ...

Wegovy is now approved by the FDA to treat metabolic-associated steatohepatitis in adults with moderate-to-advanced fibrosis ...

The approval was based on Part 1 (72 week data) of the randomized, double-blind, placebo-controlled phase 3 ESSENCE trial.

The drug received accelerated approval for use in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Novo Nordisk stock jumped Monday after the FDA approved the company's obesity drug, Wegovy, as a treatment for MASH.