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
PR Newswire•21/09/2026•07:00 ET
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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 PR Newswire
—sNDA Under Review for Full Approval Is Based on Positive Results From Phase 3b ENCORE Study—
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