1차 출처 기록
중대FDA 라벨 업데이트
MannKind: FDA, Afrezza를 5년간의 폐 악성종양 PMR(시판 후 요건)에서 해제
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.
핵심 사실
출처 발췌
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