MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes
If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy sBLA submission based on data from the Phase 3 INHALE-1 study