Regulation - Sanofi

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Keryx' shares fall as FDA approves kidney drug, but with warnings

Keryx' shares fall as FDA approves kidney drug, but with warnings

07-09-2014

US drugmaker Keryx Biopharmaceuticals has received approval from the US Food and Drug Administration…

ferric citrateKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationRenvelaSanofiUSAZerenex

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

Sanofi's NDA for basal insulin Toujeo accepted by FDA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

08-07-2014

The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

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In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE)…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 final guidance again rejects Sanofi’s Zaltrap for colorectal cancer

25-03-2014

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

Northern EuropeOncologyPharmaceuticalPricingRegulationSanofiUKZaltrap

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

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

Added benefit of Sanofi’s Aubagio not proven, says IQWiG

Added benefit of Sanofi’s Aubagio not proven, says IQWiG

08-01-2014

In yet another negative opinion from the German Institute for Quality and Efficiency in Health Care (IQWiG)…

AubagioGermanyNeurologicalNorthern EuropePharmaceuticalPricingRegulationSanofi

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

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

Brazil Court annuls marketing approval for sub-standard Taxotere biosimilar

28-11-2013

The Superior Court of Justice in Brazil recently annulled marketing approval for a sub-standard biosimilar…

BiosimilarsDoxelibGenericsLegalLibra LaboratoryOncologyRegulationSanofiSouth AmericaTaxotere

Following talks with FDA, Sanofi drops fedratinib development

Following talks with FDA, Sanofi drops fedratinib development

18-11-2013

French drug major Sanofi this morning revealed its decision to halt all clinical trials and cancel plans…

fedratinibOncologyPharmaceuticalRegulationResearchSanofi

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

Sanofi Pasteur MSD first vaccine company in pilot for rapid European HTA

17-10-2013

Sanofi Pasteur MSD, a vaccines joint venture between drug major Sanofi of France’s Sanofi Pasteur…

Merck & CoPharmaceuticalRegulationSanofiSanofi Pasteur MSDVaccinesZostavax

FDA allows OTC of Sanofi’s Nasacort

FDA allows OTC of Sanofi’s Nasacort

13-10-2013

The US Food and Drug Administration has approved Sanofi’s Nasacort Allergy 24HR nasal spray as an over-the-counter…

ChattemNasacort AQNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySanofi

Sanofi reaches deal in rimonabant lawsuit

Sanofi reaches deal in rimonabant lawsuit

23-09-2013

French drug major Sanofi (Euronext; SAN) has reached a $40 million settlement in a US lawsuit accusing…

MetabolicsNorth AmericaRegulationSanofi

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