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FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

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

02-03-2014

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

21-08-2013

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

30-01-2013

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

19-10-2012

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

14-10-2012

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

10-07-2012

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

31-05-2012

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

02-04-2012

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

20-12-2011

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

AubagioCardio-vascularMultaqNeurologicalPharmaceuticalRegulationResearchSanofi

Isis sees Kynamro delay; adds new drugs to pipeline

15-12-2011

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

Cardio-vascularGenzymeIsis PharmaceuticalsKynamromipomersenNephrology and HepatologyPharmaceuticalRegulationResearchSanofi

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