Insmed Announces FDA Advisory Committee Meeting to Review ALIS as a treatment for NTM Lung Disease Caused by MAC
Insmed Incorporated (INSM)
Last insmed incorporated earnings: 4/30 07:30 am
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Source: GlobeNewswire
BRIDGEWATER, N.J., June 15, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the Division of Antimicrobial Products of the U.S. Food and Drug Administration (FDA) has notified the company of a planned advisory committee meeting to review data supporting Insmed’s New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The tentative date for the meeting is set for August 7, 2018. “Currently there are no approved therapies for this rare, progressive and potentially fatal disease, representing a significant unmet need,” commented Will Lewis, President and Chief Executive Officer of Insmed. “We are pleased to have the opportunity to interact with the Advisory Committee as we work to bring forward what could be the first approv
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- 5/9/24 - Form 8-K
- 5/9/24 - Form 10-Q
- 4/1/24 - Form DEFA14A
- INSM's page on the SEC website