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CHMP positive opinion for GSK’s Cervarix two-dose schedule

CHMP positive opinion for GSK’s Cervarix two-dose schedule

28-11-2013

UK pharma giant GlaxoSmithKline says that the European Medicines Agency's Committee for Medicinal Products…

CervarixEuropeGlaxoSmithKlineOncologyPharmaceuticalRegulationVaccines

US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

26-11-2013

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

New data support GSK plan to file for approval of malaria vaccine in 2014

New data support GSK plan to file for approval of malaria vaccine in 2014

08-10-2013

Results from a large-scale Phase III trial, presented today at the Multilateral Initiative on Malaria…

GlaxoSmithKlinePharmaceuticalRegulationResearchRTS,STropical diseasesVaccines

New Zealand proposals for influenza vaccines

21-08-2013

New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list two…

Abbott LaboratoriesAsia-PacificFluarixGlaxoSmithKlineInfluvacPharmaceuticalPricingRegulationVaccines

GSK's Flulaval vaccine approved by US FDA

16-08-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has had its Flulaval quadrivalent intramuscular influenza…

FluarixFlulavalGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US FDA approves shipment of quadrivalent flu vaccine to health care providers

06-08-2013

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA

21-06-2013

The Japanese Ministry of Health, Labor and Welfare has decided to withdraw its recommendation for a vaccination…

Asia-PacificCervarixDaiichi SankyoGardasilGlaxoSmithKlineMerck & CoPharmaceuticalRegulationVaccinesWomen's Health

GlaxoSmithKline cleared for $91M flu vaccine plant in USA; Gets CRL on Q-Plan H5N1

27-03-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and The Texas A&M University System (TAMUS) say that the US…

GlaxoSmithKlineNorth AmericaPharmaceuticalProductionQ-Plan H5N1RegulationVaccines

GlaxoSmithKline gains FDA approval of four-strain seasonal influenza vaccine

17-12-2012

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline's (LSE: GSK) Fluarix…

FluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

FDA advisory panel backs GlaxoSmithKline H5N1 influenza vaccine candidate

15-11-2012

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC)…

GlaxoSmithKlineNorth AmericaPharmaceuticalPumarixRegulationVaccines

EMA reviews hypothesis on Pandemrix hypothesis; finalizes on NSAIDs and CV events

21-10-2012

The European Medicines Agency's Committee on Human Medicinal Products (CHMP) said Friday that it has…

Anti-Arthritics/RheumaticsdiclofenacGlaxoSmithKlineibuprofenInflammatory diseasesNaproxenNeurologicalPandemrixPharmaceuticalRegulationVaccines

News briefs from Threshold, Merck KGaA and GSK

18-09-2012

US biotech firm Threshold Pharmaceuticals (Nasdaq: THLD) said yesterday that data from a Phase IIb trial…

BiotechnologyErbituxEuropeGlaxoSmithKlineMerck KGaAMerck SeronoOncologyPharmaceuticalRegulationResearchSynflorixTH-302Threshold PharmaceuticalsVaccines

FDA approves GlaxoSmithKline's new combo vaccine MenHibrix

18-06-2012

The US Food and Drug Administration has approved US pharma giant GlaxoSmithKline's (LSE: GSK) MenHibrix…

GlaxoSmithKlineMenHibrixNorth AmericaPharmaceuticalRegulationVaccines

EU Commission OKs Baxter Avian flu vaccine Vepacel; drops GSK probe

05-03-2012

US drugmaker Baxter International (NYSE:BAX) says that the European Commission has granted marketing…

Anti-viralsBaxter InternationalEuropeGlaxoSmithKlineLegalPharmaceuticalRegulationSynthonVaccinesVepacel

GSK and Novartis withdraw EU extended use applications for Tyverb and Fluad, respectively

16-02-2012

The European Medicines Agency has been formally notified by UK pharma giant GlaxoSmithKline (LSE: GSK)…

EuropeFluadGlaxoSmithKlineNovartisOncologyPharmaceuticalRegulationTyverbVaccines

GlaxoSmithKline warned by US FDA over cGMP violations at UK plant; positive malaria vaccine news

20-10-2011

UK pharma giant GlaxoSmithKline ILSE: GSK) has received a warning letter from the US Food and Drug Administration…

Antibiotics and Infectious diseasesGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

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