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INSM – FDA

Mar 26, 2014 08:13 AM Insmed (INSM) on Watch for Support
Mar 26, 2014 07:02 AM Insmed (INSM) Reports ARIKAYCE Missed Primary Endpoint in Phase 2
Feb 10, 2014 08:16 AM Insmed (INSM) Receives Positive Opinion from EMA Committee for ARIKACE
Sep 11, 2013 07:32 AM Insmed (INSM) Receives Two New Patents Related to ARIKACE
Jul 1, 2013 07:31 AM Insmed (INSM) ARIKACE Meets Endpoints; Receives Fast Track Designations
Mar 27, 2013 01:11 PM Insmed (INSM) Recieves FDA Orphan Status for Arikace
Nov 13, 2012 08:06 AM Insmed (INSM) Commences CLEAR-108 Phase 3 in Europe, Canada
Aug 2, 2012 08:03 AM Insmed (INSM) Gets New Composition Matter U.S. Patent for ARIKACE
Jun 27, 2012 08:02 AM Insmed (NSM) Doses First Patient in ARIKACE Phase 2
May 7, 2012 08:02 AM Insmed (INSM) Says Clinical Hold on ARIKACE in CF Patients Lifted
Feb 10, 2012 08:05 AM Insmed (INSM) Commences ARIKACE Phase 2 in NTM Lung Disease Patients, Phase 3 in CF Patients w/ Pa
Jan 20, 2012 08:03 AM FDA Lifts Clinical Hold on Insmed (INSM) ARIKACE in NTM Patients; Continues CF Negotiations
Jan 20, 2012 08:01 AM Insmed (INSM) says FDA lifts clinical hold on arikace
Oct 14, 2011 08:10 AM FDA Continues Clinical Hold on Insmed (INSM) ARIKACE Phase 3; More Info Needed
Oct 10, 2011 08:11 AM FDA Clinical Hold Continues for Insmed's (INSM) ARIKACE
Aug 2, 2011 09:31 AM Insmed (INSM) Slammed as FDA Puts Clinical Hold on ARIKACE
Mar 3, 2011 08:24 AM Insmed's (INSM) ARIKACE Receives Positive Opinion from Pediatric Committee of EMA
Jun 25, 2009 08:12 AM Insmed (INSM) Announces That IPLEX Phase II Trial Did Not Meet A Statistically Significant Improvement
Dec 18, 2007 09:05 AM Insmed Inc (INSM) Granted Orphan Drug Designation for IPLEX
Jan 4, 2006 11:05 AM U. of Rochester Initiates Phase 2 Clinical Trial of INSM's iPlex
Dec 12, 2005 05:16 PM INSM Said FDA Approves Orphan Drug, IPLEX
Oct 25, 2005 02:18 PM FDA to Review Insmed's Complete Response to Approvable Letter for iPlex on 10/12
Sep 29, 2005 04:08 PM INSM Said iPlex Effective in Study
Sep 27, 2005 11:31 PM INSM Receives Approvable Letter for iPlex
Jun 17, 2005 09:13 AM TRCA to Withdraw Motion for a Preliminary Injunction Against Insmed
Jun 10, 2005 07:20 AM INSM: FDA Delays PDUFA Date for SomatoKine
May 31, 2005 04:10 PM INSM Reports Positive Results from Its Pivotal Clinical Trial of SomatoKine
Apr 26, 2005 08:43 AM INSM Initiates Phase II Trial With SomatoKine(R) in Type A Extreme Insulin Resistance
Apr 20, 2005 08:07 AM INSM Initiates Phase II HIV-Associated Lipodystrophy Trial
Apr 13, 2005 11:33 AM INSM Grants FDA Priority Review for SomatoKine
Mar 10, 2005 11:03 AM FDA Accepts for Review INSM's NDA for SomatoKine

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