MannKind: Inaprubahan ng FDA ang Afrezza para sa pediatric diabetes (edad 6+)

Inaprubahan ng FDA ang supplemental BLA para sa Afrezza sa mga bata at kabataan na may edad 6 at mas matanda na may type 1 o type 2 diabetes. Kasama rin sa pag-apruba na ito ang pagtatapos ng huling post-marketing requirement mula sa orihinal na approval letter noong 2014.

Mahahalagang fact

Na-file: Hun 2, 2026, 12:00 PM
Kaganapan: Pag-apruba ng FDA
Direksyon: Positibo
Kumpanya: MNKDMannKind
Asset: insulin human
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · May 29, 2026 · Inaprubahan

Sipi mula sa source

8-K false 0000899460 0000899460 2026-05-29 2026-05-29 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 29, 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