09:05 AM EDT, 10/13/2025 (MT Newswires) -- MannKind ( MNKD ) said Monday that the US Food and Drug Administration has accepted for review its supplemental biologics license application for Afrezza Inhalation Powder to treat children and adolescents with type 1 or type 2 diabetes.

If approved, Afrezza, approved for adults age 18 and above, would be the first needle-free insulin option for young patients.

The biopharmaceutical company said the application is based on results from a phase 3 study of Afrezza in combination with basal insulin compared with multiple daily injections with basal insulin to treat patients age 4 for through 17.

The supplemental BLA application has been assigned a Prescription Drug User Fee Act target action date of May 29, MannKind ( MNKD ) said.