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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

Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme to resubmit Lemtrada NDA for FDA review

07-04-2014

Genzyme, the biotech subsidiary of French drug major Sanofi, said this morning that, following “constructive…

BayerBiotechnologyLemtradaNeurologicalNorth AmericaRegulationSanofiUSA

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In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…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

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

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance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

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