FDA grants priority review to Insmed ARIKAYCE sNDA
FDA granted priority review to Insmed's supplemental new drug application (sNDA) for ARIKAYCE® (amikacin liposome inhalation suspension) to treat MAC lung disease. The Prescription Drug User Fee Act (PDUFA) target action date is January 28, 2027.
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INSM INSM - 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