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Sanofi and Regeneron’s dupilumab gets Breakthrough designation from FDA

20-11-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

FDA at last approves Genzyme’s Lemtrada

FDA at last approves Genzyme’s Lemtrada

15-11-2014

The US Food and Drug Administration on Friday approved French pharma major Sanofi subsidiary Genzyme’s…

BayerBiotechnologyGenzymeLemtradaNeurologicalRegulationSanofiUSA

Genzyme’s Cerdelga gets FDA approval for Gaucher disease

Genzyme’s Cerdelga gets FDA approval for Gaucher disease

20-08-2014

The US Food and Drug Administration late yesterday approved Cerdelga (eliglustat) for the long-term treatment…

ActelionBiotechnologyCerdelgaCerezymeGenzymeRare diseasesRegulationSanofiUSAZavesca

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

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In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…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

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

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

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

Regulatory briefs: Sanofi's Fluzone; Roche' RoActemra; Takeda's Rienso

10-06-2013

French pharma major Sanofi (Euronext: SAN) today (June 10) announced that the US Food and Drug Administration…

Anti-Arthritics/RheumaticsBiotechnologyPharmaceuticalRegulationRocheSanofiTakeda PharmaceuticalsVaccines

Sanofi and Transgene collaborate on immunotherapy treatments; NAS designation of Aubagio disputed

25-03-2013

Drug major Sanofi (Euronext: SAN) and fellow France-based biotech firm Transgene SA (NYSE-Euronext: TNG)…

AubagioBiotechnologyEuropeGenzymeImmunologicalsNeurologicalPharmaceuticalProductionRegulationSanofiTransgene

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval

12-02-2013

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

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

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