原始出處紀錄
重大FDA 仿單更新
MannKind：FDA 解除 Afrezza 五年肺部惡性腫瘤 PMR
FDA 解除 MannKind 進行 8,000-10,000 名患者、為期五年的肺部惡性腫瘤研究的上市後要求。唯一剩餘的 PMR 為兒科療效/安全性評估；4-17 歲的 sBLA PDUFA 目標行動日期為 2026 年 5 月 29 日。
關鍵事實
- 申報時間
- 2026年5月28日 下午12:37
- 事件
- FDA 仿單更新
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
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