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Breckenridge Pharma files ANDA for generic of Sanofi’s Jevtana

12-02-2015

Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application…

Breckenridge PharmaceuticalsGenericsJevtanaOncologyPatentsRegulationSanofiUSA

Sanofi and Regeneron’s Praluent BLA gains priority review from US FDA

26-01-2015

The US Food and Drug Administration has accepted for priority review the Biologics License Application…

alirocumabAmgenBiotechnologyCardio-vascularevolocumabPraluentRegeneron PharmaceuticalsRegulationSanofiUSA

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

Sanofi granted European marketing authorization for Cerdelga in Gaucher disease

22-01-2015

French drug major Sanofi and its subsidiary Genzyme have been granted marketing authorization by the…

BiotechnologyCerdelgaGeneticsGenzymeRegulationSanofi

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

EMA accepts Sanofi and Regeneron's MMA for Praluent for review

12-01-2015

French drug major Sanofi and US biotech company Regeneron have announced that the European Medicines…

alirocumabBiotechnologyCardio-vascularEuropeRegeneronRegulationSanofi

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

Sanofi Pasteur gains FDA approval of Fluzone Intradermal Quadrivalent for adults

13-12-2014

French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food…

Anti-viralsFluzonePharmaceuticalRegulationSanofiSanofi PasteurUSAVaccines

FDA approves Sanofi’s Priftin for latent TB

FDA approves Sanofi’s Priftin for latent TB

03-12-2014

French pharma major Sanofi says that the US Food and Drug Administration has approved Priftin (rifapentine),…

Antibiotics and Infectious diseasesPharmaceuticalPriftinRegulationSanofiUSA

Regeneron and Sanofi granted breakthrough designation for dupilumab

Regeneron and Sanofi granted breakthrough designation for dupilumab

25-11-2014

US biotech Regeneron Pharmaceuticals and French pharma major Sanofi have said that the US Food and Drug…

BiotechnologyDermatologicalsdupilumabRegeneronRegulationSanofiUSA

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