FDA Advisory Committee Votes 12-2 in Favor of the Safety and Effectiveness of Insmed’s ALIS for the Treatment of NTM Lung Disease Caused by MAC for Adult Patients with Limited or No Treatment Options
07. August 2018 17:30 ET
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Insmed, Inc.
--Advisory committee supports surrogate endpoint of sputum culture conversion-- --ALIS currently under FDA Priority Review; PDUFA action date set for September 28, 2018-- BRIDGEWATER, N.J., Aug. ...
Insmed Reports Second Quarter 2018 Financial Results and Provides Business Update
02. August 2018 07:30 ET
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Insmed, Inc.
PDUFA (Prescription Drug User Fee Act) Action Date for ALIS (Amikacin Liposome Inhalation Suspension) Set for September 28, 2018Actively Preparing for Potential Product Launch in Early Q4 2018 ...
Insmed to Host Second Quarter 2018 Financial Results Conference Call on Thursday, August 2, 2018
26. Juli 2018 08:00 ET
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Insmed, Inc.
BRIDGEWATER, N.J., July 26, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced...
Insmed Announces FDA Advisory Committee Meeting to Review ALIS as a treatment for NTM Lung Disease Caused by MAC
15. Juni 2018 08:00 ET
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Insmed, Inc.
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...
Insmed to Present at Three June Conferences
07. Juni 2018 08:00 ET
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Insmed, Inc.
BRIDGEWATER, N.J., June 07, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced...
Insmed Announces Presentations at the American Thoracic Society 2018 International Conference
22. Mai 2018 17:15 ET
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Insmed, Inc.
Data support the benefit of treating patients with a combination of ALIS (Amikacin Liposome Inhalation Suspension) and guideline-based therapy (GBT) for the treatment of nontuberculous mycobacterial...
Insmed Appoints Leo Lee to its Board of Directors
17. Mai 2018 16:05 ET
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Insmed, Inc.
BRIDGEWATER, N.J., May 17, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced...
Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC
16. Mai 2018 08:00 ET
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Insmed, Inc.
PDUFA Action Date Set for September 28, 2018 BRIDGEWATER, N.J., May 16, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of...
Insmed Reports First Quarter 2018 Financial Results and Provides Business Update
02. Mai 2018 07:30 ET
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Insmed, Inc.
Submitted NDA to FDA for Amikacin Liposome Inhalation Suspension (ALIS) in NTM lung disease caused by MAC; anticipates priority reviewActively preparing for potential product launch of ALIS in...
Insmed to Present at the Deutsche Bank 43rd Annual Health Care Conference
01. Mai 2018 08:00 ET
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Insmed, Inc.
BRIDGEWATER, N.J., May 01, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced...