The U.S. FDA approved Eli Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes, expanding the drug’s label beyond glycemic control and weight loss. The approval follows results from SURPASS-CVOT, a head-to-head cardiovascular outcomes trial comparing tirzepatide against dulaglutide. FDA’s decision is based on a non-inferiority analysis for the primary major adverse cardiovascular endpoint (MACE-3), with an observed 8% lower rate of cardiovascular death, heart attack, or stroke versus the comparator. The company highlighted gastrointestinal adverse events as the most common side effects, concentrated during dose escalation. Separately, Takeda’s hepcidin mimetic Mimrylo (rusfertide) also received FDA clearance in polycythemia vera (PV), positioning an erythrocytosis treatment option backed by phase 3 efficacy data. The dual approvals underscore ongoing regulatory focus on metabolic, hematology, and cardiometabolic endpoints. Taken together, the actions signal continued expansion of incretin-based therapies into cardiovascular risk reduction while consolidating the hepcidin-activating approach for PV management.