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Insmed's ARIKAYCE SNDA Gets FDA Priority Review; PDUFA Set For Jan 2027
Source: Nasdaq
Healthcare & BiotechRegulation & Legislation
Insmed said the FDA accepted its supplemental New Drug Application for ARIKAYCE, an amikacin liposome inhalation suspension, for review in Mycobacterium avium complex (MAC) lung disease. The acceptance advances a potential label-expansion pathway for the therapy, though no approval decision or review timeline was disclosed.
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