MannKind Corp., MNKD, FDA Calendar, PDUFA Date

Company Name	MannKind Corp. MNKD
Drug Name	Afrezza (sBLA)
Event Name	FDA decision on Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes
Event Date	05/29/2026
Outcome Date
Outcome	FDA approved Afrezza Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes on May 29, 2026
Drug Status	If approved, Afrezza would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy.
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Market Potential
Other Approvals	Afrezza (insulin human) Inhalation Powder was first approved by the FDA for adults in June 2014 and is also approved in India and Brazil
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