FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027
FDA priority review and January 28, 2027 PDUFA date signal regulatory catalyst for ARIKAYCE in MAC lung disease.
What changed
FDA priority review and January 28, 2027 PDUFA date signal regulatory catalyst for ARIKAYCE in MAC lung disease.
Why it matters
FDA priority review and January 28, 2027 PDUFA date signal regulatory catalyst for ARIKAYCE in MAC lung disease. — impact context not separately stored; see What changed.
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Sep 21, 2026 03:46 PM ET