Regulation - Sanofi, Cardio-vascular


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FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab


French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

Actavis challenges Multaq and Colcrys patents


Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant…

ActavisAnti-Arthritics/RheumaticsCardio-vascularColcrysGenericsLegalMultaqNorth AmericaPatents & Trade marksRegulationSanofiTakeda PharmaceuticalsUSA

FDA should warn against prolonged use of Plavix for stent patients, says US consumer group


The US Food and Drug Administration should warn patients and doctors that taking the widely prescribed…

Bristol-Myers SquibbCardio-vascularNorth AmericaPharmaceuticalPlavixRegulationSanofi

FDA clears Sanofi and Isis' Kynamro for inherited cholesterol disorder


The US Food and Drug Administration yesterday approved Sanofi (Euronext: SAN) subsidiary Genzyme's orphan…

BiotechnologyCardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

FDA advisory panel votes 9 to 6 to approve Genzyme's Kynamro


The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory yesterday voted by…

BiotechnologyCardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

Watson gets FDA approval for generic Sanctura XR and Avapro


US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has received approval from the US Food and Drug…

AllerganAvaproCardio-vascularGenericsGenito-urinaryNorth AmericaRegulationSanctura XRSanofiWatson Pharmaceuticals

Sanofi pulls European and other regulatory filings for Mulsevo


The European Medicines Agency says it has been formally notified by French drug major Sanofi (Euronext:…

Cardio-vascularEuropeMulsevoNorth AmericaPharmaceuticalRegulationSanofisemuloparin

Isis earns $25 million milestone from Genzyme as US FDA accepts Kynamro NDA


The US Food and Drug Administration has accepted for filing the New Drug Application for Kynamro (mipomersen…

BiotechnologyCardio-vascularFinancialGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRegulationSanofi

Genzyme and Isis file Kynamro NDA in USA


Biotech firm Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN), has submitted a New Drug…

Cardio-vascularGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRare diseasesRegulationSanofi

FDA strengthens warnings on Sanofi’s Multaq; Aubagio disappoints


The US Food and Drug Administration (FDA) has completed a safety review of French drug major Sanofi’s…


Isis sees Kynamro delay; adds new drugs to pipeline


California, USA-based Isis Pharmaceuticals (Nasdaq: ISIS) announced yesterday that there will be a slight…

Cardio-vascularGenzymeIsis PharmaceuticalsKynamromipomersenNephrology and HepatologyPharmaceuticalRegulationResearchSanofi

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