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GENZ Related FDA

Feb 10, 2011 08:03 AM Valeant (VRX) Acquires Canadian Rights to Cholestagel from Genzyme (GENZ)

Jan 20, 2011 07:12 AM Genzyme (GENZ) Makes €250M Investment in Myozyme and Lumizyme

Oct 20, 2010 07:17 AM Genzyme (GENZ) Files Patent Infringement Suit Against Medicis Pharma (MRX)

Oct 14, 2010 09:37 AM Genzyme Corp. (GENZ) Presents Positive Results from Alemtuzumab Phase 2 In Patients With MS

Sep 20, 2010 09:20 AM Genzyme Corp. (GENZ) Receives Approval for Synvisc in Japan, Plans to Launch by the End of 2010

Sep 1, 2010 07:18 AM Genzyme (GENZ) and Isis Pharma (ISIS) Present Data from heFH Phase 3; Meets Primary Endpoint

Aug 23, 2010 09:21 AM Follow-Up Results from Phase 2 Trial of Genzyme's (GENZ) Eliglustat Tartrate to be Published in Blood

Aug 4, 2010 08:25 AM Genzyme (GENZ) and Isis Pharma (ISIS) Announce Results of Mipomersen Phase 3's; Both Met Secondary Endpoints

Jul 12, 2010 04:05 PM Watson Pharma (WPI) Subsidiary Confirms Renvela Patent Challenge

Jun 29, 2010 02:51 PM Genzyme (GENZ) Sees Supply of Cerezyme Flat in July, Supply of Fabrazyme Flat Over Next 3 Months; Expects Supply Increases in Following Months

Jun 14, 2010 02:52 PM Genzyme (GENZ) Receives FDA Fast Track Designation for alemtuzumab

Jun 14, 2010 02:49 PM Genzyme's (GENZ) Alemtuzumab for MS Granted Fast Track Status by FDA

May 25, 2010 04:43 PM Watson Pharma (WPI) Confirms Subsidiary Filing NDA for Generic Renvela, Patent Challenge by Genzyme (GENZ)

May 25, 2010 10:58 AM FDA Approves Genzyme's (GENZ) Lumizyme for Late-Onset Pompe Disease

May 24, 2010 02:03 PM Genzyme (GENZ) Discloses Final Terms of Consent Decree Regarding Allston Plant

Apr 15, 2010 09:10 AM Genzyme (GENZ) Reports Results from Late-Onset Study on Myozyme

Apr 14, 2010 08:39 AM Genzyme Corp (GENZ) Announces Positive Data from CAMMS223 Phase 2

Mar 24, 2010 08:33 AM FDA to Take Enforcement Action Related to Genzyme's (GENZ) Allston Plant

Mar 15, 2010 09:13 AM Genzyme (GENZ) and Isis Pharma (ISIS) Mipomersen Phase 3 Meets Primary Endpoint

Mar 3, 2010 08:47 AM Genzyme (GENZ), PTC Therapeutics Report Prelim. Results from Phase 2b Trial of Ataluren for nmDBMD

Feb 22, 2010 08:05 AM Genzyme (GENZ) Receives Notice of Icahn Partners' Nomination

Feb 10, 2010 07:45 AM Genzyme (GENZ) and Isis (ISIS) Said Mipomersen Phase 3 Study Meets Primary Endpoint

Jan 21, 2010 10:26 AM Genzyme (GENZ) Receives Six-Month PDUFA from U.S. FDA for Lumizyme BLA

Jan 21, 2010 10:25 AM Genzyme's (GENZ) Lumizyme Receives 6-Month FDA Review; Date Set for June 17

Jan 15, 2010 09:05 AM Impax Laboratories (IPXL) Confirms Challenge Initiation of Patents Listed by Daiichi Sankyo's WELCHOL Tablets

Dec 7, 2009 03:37 PM Genzyme (GENZ) Reports Positive Data in Phase 3 Trial of Campath in Combination with Fludara

Nov 16, 2009 09:19 AM Genzyme (GENZ) Receives FDA Complete Response Letter Regarding Application to Market Lumizyme

Nov 13, 2009 07:20 PM Genzyme's (GENZ) Quality Control Detects Foreign Particles in Five Enzyme Replacement Products; Issues Letters to U.S. Healthcare Providers

Nov 13, 2009 02:16 PM Goldman Sachs Says FDA News on Genzyme (GENZ) is a "Significant Negative Surprise"

Nov 13, 2009 12:43 PM Deutsche Bank Says Genzyme (GENZ) FDA Warning May Not Be a Big Deal

Nov 13, 2009 12:04 PM BioMarin (BMRN) Responds to News of Contamination at Genzyme (GENZ) Plant; Says Aldurazyme, Naglazyme Won't Be Impacted

Nov 13, 2009 11:47 AM FDA Says Genzyme's (GENZ) Rare Disease Drugs May Be Contaminated -Bloomberg

Oct 6, 2009 01:18 PM FDA Provides Complete Response Letter for Genzyme's (GENZ) NDA for Clolar(R); Company to Request a Meeting Discussing Optimal Path Forward

Sep 24, 2009 08:48 AM Genzyme's (GENZ) Campath Meets Primary Endpoint in Phase 3 Combination Therapy Trial for Chronic Lymphocytic Leukemia

Sep 11, 2009 11:46 AM Genzyme (GENZ) Reports 4-Yr Follow-Up on Alemtuzumab Shows Durable Treatment Benefit

Jul 31, 2009 11:36 AM Genzyme (GENZ) Said FDA Will Re-Inspect Allston Landing Plant

May 21, 2009 12:05 PM Genzyme (GENZ) Submits All Information Requested by FDA for Lumizyme

May 20, 2009 09:20 AM Genzyme (GENZ) and Isis (ISIS) Announce that Mipomersen Phase 3 Study in Patients with Homozygous Familial Hypercholesterolemia Met Primary Endpoint

Apr 6, 2009 12:51 PM Impax Labs (IPXL) Initiates Challenge of Renvela-Related Patents Listed by Genzyme

Mar 2, 2009 06:33 PM Genzyme (GENZ) Receives Complete Response Letter From FDA For Lumizyme Application; Anticipates Negative Impact To 2009 Earnings

Feb 26, 2009 09:39 AM Genzyme (GENZ) Announces FDA Marketing Approval for Synvisc-One; EC Approves Production of Myozyme at 4000L Scale

Jan 12, 2009 09:39 AM Genzyme (GENZ) and Isis (ISIS) Begin New Clinical Trials of Mipomersen

Dec 15, 2008 05:05 PM Genzyme's (GENZ) Mozobil Receives FDA Approval

Dec 9, 2008 05:00 PM FDA Advisory Committee Unanimously Recommends Approval of Genzyme's (GENZ) Synvisc-One

Dec 9, 2008 07:54 AM Genzyme (GENZ) Reports Clolar(R) Data Further Supporting Potential of Product to Treat Adult AML Patients

Jul 23, 2008 08:37 AM Genzyme (GENZ) Expects FDA Approval For Myozyme By End of Year

Jun 17, 2008 08:32 AM Genzyme (GENZ) Submits U.S. and European Applications for Approval of Mozobil

May 7, 2008 02:05 PM Preliminary Results from Phase 2 Genzyme (GENZ) Study Highlight Potential of Novel Oral Compound for Gaucher Disease

Apr 21, 2008 04:17 PM Genzyme (GENZ) Lowers Guidance After FDA Opinion on Myozyme

Mar 19, 2008 12:03 PM Genzyme (GENZ) Withdraws Bioenvision's European Filing of Evoltra in Elderly AML Patients

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