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First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

Merck & Co’s melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

05-09-2014

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s…

KeytrudaMerck & CoOncologypembrolizumabPharmaceuticalRegulationUSA

Merck’s Belsomra gets FDA approval for insomnia

Merck’s Belsomra gets FDA approval for insomnia

14-08-2014

Pharma giant Merck & Co has received US Food and Drug Administration approval for its insomnia treatment…

BelsomraMerck & CoNeurologicalPharmaceuticalRegulationSedativesUSA

EMA accepts Merck’s pembrolizumab MAA for review

EMA accepts Merck’s pembrolizumab MAA for review

01-07-2014

US pharma giant Merck & Co says that the European Medicines Agency has accepted for review a Marketing…

EuropeMerck & CoOncologypembrolizumabPharmaceuticalRegulation

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

30-06-2014

Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase…

EmendMerck & CoOncologyPharmaceuticalRegulationResearch

Merck and Endocyte pull CMA for vintafolide and companion imaging component in EU

20-05-2014

US pharma giant Merck & Co and Endocyte have withdrawn their conditional marketing authorization applications…

EndocyteEuropeMerck & CoOncologyPharmaceuticalRegulationResearchvintafolide

FDA approves Merck & Co’s new blood thinner Zontivity

FDA approves Merck & Co’s new blood thinner Zontivity

09-05-2014

The US Food and Drug Administration yesterday approved US pharma giant Merck & Co’s Zontivity (vorapaxar)…

Cardio-vascularMerck & CoPharmaceuticalRegulationUSAZontivity

Merck & Co updates on near-term opportunities and strategy

Merck & Co updates on near-term opportunities and strategy

07-05-2014

US pharma giant Merck & Co, which has just sold its consumer health care business to Bayer for $14.2…

Merck & CoPharmaceuticalRegulationResearch

FDA approves Merck’s Ragwitek for short ragweed pollen allergies

18-04-2014

The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

EMA/CHMP backs approval of Merck ovarian cancer drug Vynfinit and companion diagnostics

21-03-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

EndocyteEuropeFolcepriMerck & CoNeocepriOncologyPharmaceuticalRegulationVynfinit

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

Pharma Summit: Merck’s European president Bruno Strigini highlights importance of innovation

17-03-2014

The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini…

Anti-viralsCanadaDiabetesEuropeInterviewsMerck & CoMK-3475OncologyPharmaceuticalRegulationUKVaccines

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

Astellas gains Japanese clearance for diabetes drug Suglat

Astellas gains Japanese clearance for diabetes drug Suglat

20-01-2014

Japanese drug major Astellas Pharma has obtained the marketing approval of selective SGLT2 inhibitor…

Asia-PacificAstellas PharmaDiabetesipragliflozinKotobuki PharmaceuticalMerck & CoPharmaceuticalRegulationSuglat

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

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

10-12-2013

The US Food and Drug Administration Allergenic Products Advisory Committee will review US pharma giant…

ALK AbelloImmunologicalsMerck & CoPharmaceuticalRegulationUSA

New Zealand views access to sugammadex and atomoxetine and baclofen injection funding

02-12-2013

New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on the following proposals…

Asia-PacificBridionEli LillyLioresal IntrathecalMerck & CoNeurologicalNew ZealandPharmaceuticalRegulationStrattera

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

Sanofi Pasteur MSD first vaccine company in pilot for rapid European HTA

17-10-2013

Sanofi Pasteur MSD, a vaccines joint venture between drug major Sanofi of France’s Sanofi Pasteur…

Merck & CoPharmaceuticalRegulationSanofiSanofi Pasteur MSDVaccinesZostavax

UK NICE final draft guidance on treatment for chronic hepatitis C

UK NICE final draft guidance on treatment for chronic hepatitis C

11-10-2013

The UK drugs watchdog the National Institute of Health and Care Excellence this morning confirmed its…

Anti-viralsEuropeMerck & CoPegasysPharmaceuticalPricingRegulationRocheViraferon

EU regulator finds no added pancreatic risks for GLP-1 diabetes drugs

26-07-2013

Having finalized a review of glucagon-like peptide 1 (GLP-1)-based diabetes therapies, the European Medicines…

AstraZenecaBoehringer IngelheimBristol-Myers SquibbBydureonDiabetesEli LillyEuropeJanuviaMerck & CoNovo NordiskOnglyzaPharmaceuticalRegulationTradjentaVictoza

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