INSM PDUFA Date: ARIKAYCE Page updated November 5, 2026 · next FDA decision on the calendar · Data as of Nov 5, 2026 5:03 AM ET FDA decision (PDUFA) target Jan 28, 2027 · INSMED Inc · MAC lung disease, as part of a combination antibacterial drug regimen
Key facts FDA PDUFA target date 2027-01-28
Drug / candidate ARIKAYCE (amikacin liposome inhalation suspension)
Indication MAC lung disease, as part of a combination antibacterial drug regimen
Company INSMED Inc
Market-cap tier Large
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See every 2027 PDUFA date → All January 2027 PDUFA dates → FAQ When is the INSM PDUFA date? The FDA PDUFA target date for INSM (INSMED Inc) is 2027-01-28 for ARIKAYCE (amikacin liposome inhalation suspension). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is INSM's drug ARIKAYCE? ARIKAYCE (amikacin liposome inhalation suspension) is INSMED Inc's candidate under FDA review for MAC lung disease, as part of a combination antibacterial drug regimen.
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