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US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

16-05-2014

The US Food and Drug Administration has issued a Complete Response Letter regarding the Biologics License…

Cardio-vascularNovartisPharmaceuticalReasanzRegulationserelaxinUSA

US FDA advisory panel votes against approval of Novartis’ AHF drug

US FDA advisory panel votes against approval of Novartis’ AHF drug

28-03-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee yesterday voted…

Cardio-vascularNorth AmericaNovartisPharmaceuticalReasanzRegulationserelaxinUSA

Modest growth forecast for global CD market

02-12-2013

The global market for cardiovascular disease - comprised of heart failure, myocardial infarction and…

AstraZenecaAZD6140BAY81-8781BayerCardio-vascularLCZ696Markets & MarketingNovartisPharmaceuticalPricingserelaxin

New data show serelaxin improved symptoms and mortality across multiple subgroups of patients with AHF

02-09-2013

Results from a new analysis of the Phase III RELAX-AHF study published today in the European Heart Journal…

Cardio-vascularNovartisPharmaceuticalResearchRLX030serelaxin

"Breakthrough" status from FDA for Novartis' serelaxin (RLX030) for acute heart failure

21-06-2013

The US Food and Drug Administration has granted Breakthrough Therapy designation status to RLX030 (serelaxin),…

Cardio-vascularNorth AmericaNovartisPharmaceuticalRegulationRLX030serelaxin

Novartis' serelaxin reduces mortality in AHF patients

25-09-2012

Phase III study results released by Swiss drug major Novartis (NOVN: VX) yesterday show that its investigational…

Cardio-vascularNovartisPharmaceuticalRelaxinResearchRLX030serelaxin

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Eleven Biotherapeutics

Eleven Biotherapeutics

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