MannKind: Inilabas ng FDA ang Afrezza mula sa 5-taong pulmonary malignancy PMR

Inilabas ng FDA ang MannKind mula sa post-marketing requirement na magsagawa ng 8,000-10,000 pasyente, limang taong pag-aaral ng pulmonary malignancy para sa Afrezza. Ang tanging natitirang PMR ay ang pagtatasa ng pediatric efficacy/safety; ang sBLA para sa edad 4-17 ay may PDUFA target action date na Mayo 29, 2026.

Mahahalagang fact

Na-file: May 28, 2026, 12:37 PM
Kaganapan: Update sa FDA label
Direksyon: Positibo
Kumpanya: MNKDMannKind
Asset: insulin human
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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