Regulation - Merck & Co, North America

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FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

28-01-2014

The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available…

Alk-AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

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

Unanimous FDA panel support for Merck & Co’s Grastek

Unanimous FDA panel support for Merck & Co’s Grastek

13-12-2013

The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted…

Alk-AbelloGrastekGrazaxImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25-10-2013

Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

FDA grants Merck’s hepatitis C treatment breakthrough designation

FDA grants Merck’s hepatitis C treatment breakthrough designation

23-10-2013

US pharma giant Merck & Co has announced that the US Food and Drug Administration has granted MK-5172/MK-8742…

Anti-viralsMerck & CoNorth AmericaPharmaceuticalRegulation

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

US FDA delays Merck & Co's insomnia drug suvorexant, issuing CRL

01-07-2013

There was disappointment for US drug giant Merck & Co (NYSE: MRK), which said that it has received a…

Merck & CoNeurologicalNorth AmericaPharmaceuticalRegulationsuvorexant

US FDA advisory panel backs approval of Merck & Co's suvorexant, but only at lower doses

23-05-2013

The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee…

Merck & CoNeurologicalNorth AmericaPharmaceuticalRegulationsuvorexant

US FDA accepts Merck & Co's BLA ragweed pollen allergy immunotherapy

09-05-2013

US pharma giant Merck & Co (NYSE: MRK) revealed yesterday (May 8) that the Biologics License Application…

Alk-AbelloBiotechnologyImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

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

FDA awards "Breakthrough Therapy" status for Merck & Co's lambrolizumab

25-04-2013

US pharma giant Merck & Co (NYSE:MRK) says that the US Food and Drug Administration has designated lambrolizumab…

lambrolizumabMerck & CoNorth AmericaOncologyPharmaceuticalRegulation

Breakthrough status for Pfizer's palbociclib; Merck & Co Noxafil NDA accepted

11-04-2013

Global pharma behemoth Pfizer (NYSE: PFE) is the latest to gain a "Breakthrough Therapy" designation…

Antibiotics and Infectious diseasesMerck & CoNorth AmericaNoxafilOncologypalbociclibPfizerPharmaceuticalRegulation

Briefs: Glenmark challenges Bayer patent; FDA delays Merck & Co's sugammadex

18-03-2013

Indian drugmaker Glenmark Generics confirms that it seeking US Food and Drug Administration approval…

BayerBridionDermatologicalsFinacea GelGenericsGlenmark PharmaceuticalsMerck & CoNeurologicalNorth AmericaPatentsPharmaceuticalRegulationsugammadex

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

Merck & Co submits ragweed AIT BLA to the FDA

11-03-2013

US pharma giant Merck & Co (NYSE: MRK) has submitted a Biologics License Application (BLA) to the US…

ALK AbelloFinancialImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

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

FDA accepts Merck & Co's suvorexant; panel backs Novo's Tresiba and Ryzodeg

09-11-2012

US drug giant Merck & Co (NYSE: MRK) says that the New Drug Application for suvorexant, the company's…

DegludecDiabetesMerck & CoNeurologicalNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegsuvorexantTresiba

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

Batch of mixed opinions from FDA advisory panels

21-06-2012

Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of…

carfilzomibKyprolisMerck & CoNorth AmericaOncologyOnyx PharmaceuticalsPfizerPharmaceuticalPneumovaxPrevnarRegulationSanofisemuloparinVaccines

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