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FDLI SmartBrief 03/25/2019 09:40
Sanofi and Lexicon Pharmaceuticals' new drug application for Zynquista, or sotagliflozin, to treat type 1 diabetes in adult patients in combination with insulin, has received a complete response letter.
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STAT 03/25/2019 09:17
The Food and Drug Administration declined to approve a drug developed by Sanofi (SNY) and Lexicon Pharmaceuticals (LXRX) intended for use with insulin in patients with Type 1 diabetes, Reuters writes.
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Pharmafile 03/25/2019 07:09
Sanofi and Lexicon's Zynquista denied type 1 diabetes approval by FDA complete response letter.
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pharmaphorum 03/25/2019 04:58
Sanofi’s hopes of getting its dual SGLT inhibitor sotagliflozin approved alongside insulin for type 1 diabetes in the US have been dashed by the FDA.
More from pharmaphorum: 03/22/2019 15:46
22.03.2019 19:15:00 CET FDA issues Complete Response Letter for Zynquista™ (sotagliflozin) PARIS and THE WOODLANDS, TX - March 22, 2019 - The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista™ (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.
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ENDPOINTS 03/22/2019 15:17
Sanofi’s shot at a last-place showing for its SGLT1/SGLT2 diabetes drug has ended in a painful pratfall ahead of the finish line.
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FiercePharmaManufacturing 03/22/2019 14:44
RELATED: FDA panel split on Sanofi's Type 1 diabetes hopeful Zynquista The FDA’s Friday decision marks a setback for Sanofi, as the company could badly use the revenue from a new launch.
More from FiercePharmaManufacturing: 03/18/2019 12:34
REUTERS/Charles Platiau Sanofi has an age limit of 65 for its CEO.
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GlobeNewswire 03/13/2019 14:30
About Sanofi Sanofi is dedicated to supporting people through their health challenges.
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Sanofi has secured priority review from the US Food and Drug Administration (FDA) for its human monoclonal antibody Dupixent (dupilumab) as an add-on maintenance treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP.
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Korean Biomedical Review 03/07/2019 03:22
Sanofi Genzyme Korea, a subsidiary of Sanofi, said Thursday that the Ministry of Health and Welfare has decided to expand insurance benefit for Cerezyme (Ingredient: imiglucerase), its oral treatment for Gaucher disease.
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