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Boehringer Ingelheim files BLA with FDA for Pradaxa antidote idarucizumab

02-03-2015

German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA)…

BiotechnologyBoehringer IngelheimCardio-vascularidarucizumabPradaxaRegulationUSA

Novartis' heart failure drug LCZ696 granted FDA priority review

Novartis' heart failure drug LCZ696 granted FDA priority review

14-02-2015

The US Food and Drug Administration has granted priority review designation for combination pill LCZ696…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationsacubitrilUSAvalsartan

US FDA approves Symplmed and Servier’s Prestalia

US FDA approves Symplmed and Servier’s Prestalia

27-01-2015

Privately-held US drugmaker Symplmed Pharmaceuticals says that the US Food and Drug Administration has…

Cardio-vascularPharmaceuticalPrestaliaRegulationServierSymplmedUSA

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

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

UK’s NICE backs Bayer’s Xarelto for reducing risk of secondary events in ACS

23-01-2015

The National Institute for Health and Care Excellence (NICE), the health costs watchdog for England,…

BayerCardio-vascularPharmaceuticalPricingRegulationUKXarelto

Bayer's Xarelto gets label update in Europe

Bayer's Xarelto gets label update in Europe

20-01-2015

German drug major Bayer has updated the label for its Xarelto (rivaroxaban) in Europe.

BayerCardio-vascularGermanyPharmaceuticalRegulationXarelto

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

FDA approves Daiichi Sankyo’s anti-clotting drug Savaysa

09-01-2015

The US Food and Drug Administration late yesterday approved Japanese drug major Daiichi Sankyo’s anti-clotting…

Cardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulationSavaysaUSA

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