Development changeAug 15, 2025
Wegovy received accelerated FDA approval for MASH
Approval · Approved · United States
FDA granted accelerated approval for Wegovy injection for noncirrhotic MASH with moderate-to-advanced fibrosis in adults, adding another product-specific semaglutide indication.
Research sourcePublished 2025
Wegovy Prescribing Information
Regulatory · Regulatory / prescribing information
The FDA prescribing information defines approved indications, contraindications, warnings, adverse reactions, and product-specific clinical evidence for Wegovy.
Development changeMar 8, 2024
FDA approved Wegovy to reduce major cardiovascular events
Approval · Approved · United States
FDA approved a Wegovy indication to reduce cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight.
Research sourcePublished 2021
Once-Weekly Semaglutide in Adults with Overweight or Obesity
Human intervention · Randomized controlled trial
STEP 1 was a large randomized trial that established substantial direct human evidence for semaglutide in chronic weight management.