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MannKind的Afrezza正在接受FDA补充审查
2025-10-13 21:43
- MannKind Corporation (MNKD) announced that the U.S. FDA has accepted the supplemental marketing 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 target action date of May 29, 2026.
- The submission is based on results from the Phase 3 INHALE-1 study.
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