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原始来源记录

重大FDA 说明书更新

MannKind：FDA解除Afrezza的5年肺部恶性肿瘤PMR

FDA解除MannKind开展Afrezza 8,000-10,000名患者、为期五年的肺部恶性肿瘤研究的上市后要求。唯一剩余的PMR是儿科疗效/安全性评估；4-17岁适应症的sBLA的PDUFA目标行动日期为2026年5月29日。

关键事实

申报时间
2026年5月28日 12:37
事件
FDA 说明书更新
方向
积极
公司
MNKDMannKind
资产
insulin human
来源
SEC 8-K
可信度
有来源

来源摘录

8-K false 0000899460 0000899460 2026-05-27 2026-05-27 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 27, 2026 MannKind Corporation (Exact name of Registrant as Specified in Its Charter) Delaware 000-50865 13-3607736 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 1 Casper Street Danbury , Connecticut 06810 (Address of Principal Executive Offices) (Zip Code) Registrant’s Telephone Number, Including Area Code: (818) 661-5000 N/A (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing

SEC 8-K

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