MannKind wins FDA approval to expand Afrezza inhaled insulin to children ages 6+

Filed June 2, 2026 · Period ending May 29, 2026 · ~1 min read

Key Changes

• high

  FDA approved Afrezza for pediatric use in children and adolescents aged 6+ with type 1 and type 2 diabetes, expanding addressable market to include over 350,000 U.S. pediatric patients previously excluded from the product label.

  Item 8.01 verify on EDGAR →
• medium

  Approval fulfills the final postmarketing requirement from Afrezza's original 2014 FDA approval, eliminating a 12-year regulatory obligation and associated compliance uncertainty.

  Item 8.01 verify on EDGAR →