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FDA Approves Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes

Published 29 August 2026

The U.S. Food and Drug Administration has approved Eli Lilly's diabetes drug Mounjaro to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk for such events. The approval, announced by Lilly on August 29, 2026, expands the drug's label to include protection against cardiovascular death, nonfatal heart attack, and nonfatal stroke. Mounjaro, the brand name for the molecule tirzepatide, was already approved to improve blood sugar control in adults and children aged 10 and older with type 2 diabetes. The decision is based on data from the SURPASS-CVOT trial, a large-scale cardiovascular outcomes study.

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