Afrezza (insulin inhaled) PDUFA Date (MannKind)

Name: FDA PDUFA Decision: Afrezza (insulin inhaled)
Start: 2026-05-29

FDA PDUFA decision date for Afrezza (insulin inhaled) is May 29, 2026. Developed by MannKind. Indication: Type 1/2 diabetes (children and adolescents). Current status: Approved.

Indication

Type 1/2 diabetes (children and adolescents)

Regulatory details

Company: MannKind
Therapeutic area: Metabolic / Endocrine
Application type: sBLA
Review type: Standard
PDUFA date: 2026-05-29
Outcome: Approved

Afrezza (insulin inhaled) PDUFA Date — MannKind