FDA Accepts sBLA for inhaled insulin for kids and adolescents Following Positive Phase 3 Results
The FDA has accepted MannKind’s supplemental biologics license application (sBLA) for Afrezza (insulin human inhalation powder) to treat children and adolescents with type 1 or type 2 diabetes, with a PDUFA target date of May 29, 2026. The phase 3 INHALE-1 trial demonstrated Afrezza’s noninferiority to multiple daily injections, showing comparable safety and no significant […]