FDA Approves MannKind's Afrezza for Children and Adolescents With Diabetes (MNKD)

The U.S. Food and Drug Administration approved MannKind Corp.'s (MNKD) Afrezza inhaled insulin for children and adolescents aged 4 to 17 with type 1 and type 2 diabetes, the company said on May 31, 2026. The decision marks a significant expansion of the rapid-acting insulin's label, which was previously authorized only for adults. The approval was based on phase 3 clinical data demonstrating safety and efficacy in the pediatric population. Afrezza, a dry-powder inhaler, offers an alternative to injectable insulin, potentially improving adherence in younger patients. MannKind expects the expanded indication to broaden its commercial opportunity in the $20 billion-plus diabetes market. Chief Executive Officer Michael Castagna said the clearance fills a "critical unmet need" for needle-free mealtime insulin in children. The company plans to launch the pediatric indication immediately through its existing sales infrastructure. Shares of MannKind rose 4.2% in early trading following the announcement.