Regulation - Genzyme

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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

US FDA accepts resubmission of Lemtrada sBLA by Genzyme

US FDA accepts resubmission of Lemtrada sBLA by Genzyme

30-05-2014

French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme said today that the US Food and Drug…

BiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

Genzyme gains UK NICE backing for second MS drug Lemtrada

Genzyme gains UK NICE backing for second MS drug Lemtrada

28-05-2014

The UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance…

AubagioBiotechnologyGenzymeLemtradaNeurologicalPricingRegulationSanofiUK

UK’s NICE says “yes” to Genzyme’s MS drug Lemtrada

04-04-2014

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…

BiotechnologyGenzymeLemtradaNeurologicalNorthern EuropeRegulationSanofiUK

NICE recommends Sanofi’s Aubagio as new treatment option for MS

NICE recommends Sanofi’s Aubagio as new treatment option for MS

22-01-2014

In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

AubagioBiotechnologyGenzymeNeurologicalNorthern EuropePricingRegulationSanofiUK

US FDA calls for more trials on Genzyme’s Lemtrada

US FDA calls for more trials on Genzyme’s Lemtrada

30-12-2013

There was a significant disappointment this morning for French drug major Sanofi, when it revealed that…

BayerGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofiUSA

Sanofi’s Aubagio gains backing from UK’s NICE

Sanofi’s Aubagio gains backing from UK’s NICE

08-12-2013

In final draft guidance issued on Friday, the UK drugs watchdog the National Institute for Health and…

AubagioEuropeGenzymeNeurologicalPharmaceuticalPricingRegulationSanofiUK

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

05-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme,…

BiotechnologyEuropeGenzymeLemtradaNeurologicalPricingRegulationSanofiUK

Sanofi’s Lemtrada gets support from FDA advisory panel

Sanofi’s Lemtrada gets support from FDA advisory panel

14-11-2013

French drug major Sanofi (Euronext: SAN) has received support from a US Food and Drug Administration…

CNS DiseasesEuropeGenzymeLemtradaPharmaceuticalRegulationSanofi

UK's NICE calls for more information on MS treatment Aubagio

18-09-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme,…

AubagioBiotechnologyEuropeGenzymeNeurologicalPharmaceuticalPricingRegulationSanofi

Genzyme's MS drug Lemtrada approved in Europe

17-09-2013

French drug major Sanofi (Euronext: SAN) and its USA-based biotech subsidiary Genzyme revealed this morning…

AubagioBiotechnologyEuropeGenzymeLemtradaNeurologicalPharmaceuticalRegulationSanofi

Sanofi's MS drug Aubagio gains final European approval

02-09-2013

Following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products…

AubagioBiotechnologyEuropeGenzymeNeurologicalPharmaceuticalRegulationSanofi

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

Genzyme says Lemtrada sBLA for MS accepted by FDA; reports on Aubagio

28-01-2013

French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme says that the US Food and Drug…

AubagioBiotechnologyGenzymeLemtradaMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

Sanofi MS drug Aubagio gets second approval, in Australia

21-11-2012

Having already gained approval in the largest global pharma market, the USA, French drug major Sanofi's…

Asia-PacificAubagioBiotechnologyGenzymeNeurologicalPharmaceuticalRegulationSanofi

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