MANNKIND CORP - 8-K Filing
MannKind Corp (MNKD) filed to announce that the FDA released it from a postmarketing requirement for Afrezza related to assessing pulmonary malignancy risk in type 2 diabetes patients after completing a five-year trial. The remaining obligation is an assessment of efficacy and safety in pediatric patients; a supplemental BLA was accepted with a PDUFA date of May 29, 2026. Additionally, eight new sites were activated for the INHALE-1st study evaluating Afrezza plus basal insulin in youth aged 10–17 with type 1 diabetes. (Items: 8.01 Other Events)
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