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FDA expands approval of Genzyme’s Lumizyme to treat Pompe disease

FDA expands approval of Genzyme’s Lumizyme to treat Pompe disease

02-08-2014

The US Food and Drug Administration on Friday approved Lumizyme (alglucosidase alfa) for treatment of…

BiotechnologyGenzymeLumizymeMyozymeRare diseasesRegulationSanofiUSA

Sanofi and Regeneron purchase FDA priority voucher for alirocumab

Sanofi and Regeneron purchase FDA priority voucher for alirocumab

31-07-2014

French drug major Sanofi and USA-based biotech firm Regeneron Pharmaceuticals intend to use a US Food…

alirocumabBioMarin PharmaceuticalFranceMajorPharmaceuticalRare diseasesRare pediatric diseasesRegeneronRegeneron PharmaceuticalsRegulationSanofiUSA

New Zealand reaches agreement with Sanofi to fund ALS drug

11-09-2013

New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of an agreement with…

Asia-PacificNeurologicalPharmaceuticalRare diseasesRegulationRilutekSanofi

New Zealand to widen access for type 1 and type 3 Gaucher disease drug

07-08-2013

New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval of a proposal to widen…

Asia-PacificBiotechnologyCerezymeGenzymePharmaceuticalRare diseasesRegulationSanofi

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

Makers of Kynamro and Fanaptum to appeal negative CHMP opinions

17-12-2012

French drug major Sanofi's (Euronext: SAN) subsidiary Genzyme and US partner Isis Pharmaceuticals (Nasdaq:…

BiotechnologyEuropeFanaptFanaptumGenzymeIsis PharmaceuticalsKynamroNeurologicalPharmaceuticalRare diseasesRegulationSanofiVanda Pharmaceuticals

Health Canada approves Vertex' Kalydeco; and Sanofi Pasteur's Menactra

03-12-2012

Vertex Pharmaceuticals (Nasdaq: VRTX) says that Health Canada has approved Kalydeco (ivacaftor), the…

BiotechnologyKalydecoMenactraNorth AmericaPharmaceuticalRare diseasesRegulationSanofiSanofi PasteurVaccinesVertex

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

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

Genzyme Framingham plant now cleared by US and EU regulators

24-01-2012

French drug major Sanofi (Euronext: SAN) said yesterday that the US Food and Drug Administration has…

BiotechnologyFabrazymeGenzymePharmaceuticalRare diseasesRegulationSanofi

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