FDA Approves Multiple New Therapies, Including Expanded Indication for Diabetes Drug Mounjaro and First Targeted Therapy for Dermatomyositis

The U.S. Food and Drug Administration (FDA) has announced several significant approvals. Eli Lilly's Mounjaro (tirzepatide) received an expanded indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk. Priovant's Lisraya (brepocitinib) was cleared as the first targeted therapy for dermatomyositis, a rare autoimmune disease. Additionally, Gilead's Bixlenvo (bictegravir/lenacapavir) was approved as a new once-daily single-tablet regimen for virologically suppressed adults with HIV, particularly those on complex regimens. The FDA also approved updated COVID-19 vaccines targeting the JN.1-lineage XFG subvariant for the 2026-2027 respiratory season.