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FDA advisory panel votes to approve Merck & Co’s vorapaxar

FDA advisory panel votes to approve Merck & Co’s vorapaxar

16-01-2014

There was a positive outcome for US pharma giant Merck & Co yesterday, when a US Food and Drug Administration…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationUSAvorapaxarZontivity

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

Merck starts roll-out of BLA for MK-3475; vorapaxar FDA panel review

14-01-2014

US drug giant Merck & Co says it has started a rolling submission to the US Food and Drug Administration…

Cardio-vascularMerck & CoMK-3475North AmericaOncologyPharmaceuticalRegulationUSAvorapaxarZontivity

Merck & Co's NDA for vorapaxar accepted for standard review by US FDA

25-07-2013

US pharma giant Merck & Co (NYSE: MRK) has said the New Drug Application (NDA) for its once-troubled…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationvorapaxar

Cardiome gains European MA rights for Brinavess from Merck & Co

27-06-2013

Canada-based Cardiome Pharma (TSX: COM) has announced adoption of the decision by the European Commission…

BrinavessCardio-vascularCardiome PharmaEuropeLicensingMerck & CoPharmaceuticalRegulation

US FDA approves Merck & Co's combo cholesterol drug Liptruzet

06-05-2013

The Food and Drug Administration has approved pharma giant Merck & Co's (NYSE: MRK) Liptruzet (ezetimibe…

atorvastatinCardio-vascularezetimibeLiptruzetMerck & CoNorth AmericaPharmaceuticalRegulation

Merck & Co gets all clear to continue Vytorin study; FDA warns on Pfizer's Zithromax

13-03-2013

US pharma giant Merck & Co said yesterday that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT…

Antibiotics and Infectious diseasesCardio-vascularMerck & CoNorth AmericaPfizerPharmaceuticalRegulationResearchVytorinZithromax

EMA Pharmacovigilance committee calls for Tredaptive suspension; contraceptives update

13-01-2013

At meetings held last week, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee…

Cardio-vascularEuropeMerck & CoNeurologicalPharmaceuticalRegulationReproductivetetrazepamTredaptive

EMA starts review of Merck & Co's cholesterol drug Tredaptive

24-12-2012

The European Medicines Agency said on December 21 that it has started a review of the safety and efficacy…

anacetrapibCardio-vascularEli LillyEuropeevacetrapibMerck & CoPharmaceuticalRegulationTredaptive

Merck & Co to drop Tredaptive development in USA

21-12-2012

US drug giant Merck & Co (NYSE: MRK) said yesterday that, following disappointing clinical trial results…

Cardio-vascularMerck & CoNorth AmericaPharmaceuticalRegulationResearchTredaptive

Merck & Co to file for approval of two heart drugs next year

28-08-2012

US drugs giant Merck & Co (NYSE: MRK) says that, following a review of the clinical trial data and discussions…

anacetrapibCardio-vascularEuropeMerck & CoNorth AmericaPharmaceuticalRegulationResearchTredaptivevorapaxar

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