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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

"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

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