BioCentury
ARTICLE | Clinical News

FDA accepts NDA for Insmed's ALIS

May 18, 2018 7:42 PM UTC

Insmed Inc. (NASDAQ:INSM) said FDA accepted and granted Priority Review to an NDA for ALIS (amikacin liposome inhalation suspension) to treat non-tuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC). The PDUFA date is Sept. 28.

The company said it expects FDA will convene an advisory committee meeting to discuss the NDA...

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