MannKind announces US FDA accepts for review its supplemental biologics license application for inhaled ansulin (Afrezza) in children and adolescents aged 4-17 years living with diabetes

MannKind

13 October 2025 - MannKind Corporation today announced that the US FDA has accepted the supplemental biologics license application seeking approval for Afrezza (insulin human) inhalation powder in children and adolescents living with type 1 or type 2 diabetes. 

The application has been assigned a PDUFA target action date of 29 May 2026.

Read MannKind press release

Michael Wonder

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Michael Wonder