Core Insights - MannKind Corporation announced that the FDA has accepted the supplemental biologics license application (sBLA) for Afrezza, seeking approval for use in children and adolescents with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026 [1][8] Company Overview - MannKind Corporation is a biopharmaceutical company focused on innovative solutions for chronic diseases, particularly in cardiometabolic and orphan lung diseases, including diabetes [6][7] Product Information - Afrezza is a rapid-acting inhaled human insulin indicated for improving glycemic control in adults with diabetes mellitus, and it has been available for adults since June 2014 [3][4] - If approved for pediatric use, Afrezza would be the first needle-free insulin option for children in over 100 years [8] Clinical Study Details - The sBLA is based on the Phase 3 INHALE-1 study, which involved children and adolescents aged 4-17, comparing Afrezza with multiple daily injections (MDI) [2][8] - The study's six-month topline results were reported in December 2024, and full results will be presented at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November [2]