FDA lifts MannKind postmarketing study requirement for Afrezza pulmonary cancer risk

MannKind Corporation

MannKind Corporation

MNKD

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  • MannKind was released by the FDA on May 27, 2026 from a five-year Afrezza postmarketing trial requirement tied to pulmonary malignancy risk.
  • The trial had been mandated at Afrezza’s June 2014 BLA approval, calling for 8,000-10,000 type 2 diabetes patients in a randomized, controlled study.
  • Afrezza’s remaining FDA postmarketing requirement is a pediatric efficacy and safety assessment, with a supplemental BLA under review.
  • The FDA set a PDUFA target action date of May 29, 2026 for Afrezza use in patients aged 4-17 with type 1 or type 2 diabetes.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. MannKind Corporation published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-26-243074), on May 28, 2026, and is solely responsible for the information contained therein.

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