प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णFDA लेबल अपडेट
MannKind: FDA ने Afrezza को 5-वर्षीय पल्मोनरी मैलिग्नेंसी PMR से मुक्त किया
FDA released MannKind from the post-marketing requirement to conduct an 8,000-10,000 patient, five-year pulmonary malignancy study for Afrezza. The only remaining PMR is the pediatric efficacy/safety assessment; the sBLA for ages 4-17 has a PDUFA target action date of May 29, 2026.
मुख्य तथ्य
- फाइल किया गया
- 28 मई 2026, 12:37 pm
- घटना
- FDA लेबल अपडेट
- दिशा
- सकारात्मक
- कंपनी
MNKDMannKind- संपत्ति
- insulin human
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
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
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