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GlaxoSmithKline files for US and EU approval of mepolizumab

GlaxoSmithKline files for US and EU approval of mepolizumab

05-11-2014

UK pharma major GlaxoSmithKline says it has filed regulatory submissions in the USA and Europe for mepolizumab…

BarclaysBiotechnologyBosatriaEuropeGlaxoSmithKlineImmunosuppressantsmepolizumabRegulationRespiratory and PulmonaryUnited StatesUSA

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

EU marketing authorization for ViiV Healthcare HIV drug Triumeq

03-09-2014

The European Commission has granted marketing authorization for ViiV Healthcare’s Triumeq (dolutegravir…

Anti-viralsEuropeGlaxoSmithKlinePharmaceuticalRegulationTriumeqViiV Healthcare

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

Prosonix’ generic version of GSK’s Flixotide Evohaler under review in EU

02-09-2014

UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory…

EuropeEvohalerFinancialFluticasone PropionateGenericsGlaxoSmithKlineMylanProsonixRegulationRespiratory and Pulmonary

GSK files EU regulatory submission for RTS,S malaria vaccine candidate

24-07-2014

UK pharma giant GlaxoSmithKline announced today that it has submitted a regulatory application to the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRest of the WorldRTS,STropical diseasesVaccines

GSK receives EU approval for Mekinist for melanoma

GSK receives EU approval for Mekinist for melanoma

04-07-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist…

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

EU approval for GSK and Genmab’s Arzerra as first-line CLL therapy

03-07-2014

The European Commission has granted marketing authorization for a new indication for the use of UK pharma…

ArzerraEuropeGenmabGlaxoSmithKlineOncologyPharmaceuticalRegulation

GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

09-05-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline and partner…

Anoro ElliptaEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance

Positive CHMP opinion for GSK’s Mekinist in metastatic melanoma

27-04-2014

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

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

27-03-2014

UK pharma giant GlaxoSmithKline released a couple of news items yesterday, one slightly negative regarding…

DiabetesEperzanEuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulationTafinlar

FDA “Breakthrough Therapy” designation for GSK’s malaria drug tafenoquine; EU Cervarix news

FDA “Breakthrough Therapy” designation for GSK’s malaria drug tafenoquine; EU Cervarix news

22-12-2013

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for tafenoquine,…

CervarixEuropeGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationtafenoquineTropical diseases

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