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MarketBeat

MannKind Wins FDA Approval for Afrezza in Children, Opening Pediatric Diabetes Market

MannKind (NASDAQ:MNKD) said the U.S. Food and Drug Administration has approved Afrezza for pediatric patients with diabetes ages 6 and older, expanding the inhaled mealtime insulin’s label into children and adolescents.

Chief Executive Officer Michael Castagna called the decision “a truly historic moment” for the company and the diabetes community during a conference call held May 29, 2026. Castagna said the approval covers approximately 95% of children diagnosed with type 1 diabetes and represents “the first alternative to mealtime injections in 100+ years of pediatric treatments.”

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