Regulation - GlaxoSmithKline

Filter

Current filters:

GlaxoSmithKline

Popular Filters

1 to 25 of 147 results

GlaxoSmithKline files for EU extended indication for Volibris in PAH

GlaxoSmithKline files for EU extended indication for Volibris in PAH

11-12-2014

UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency…

EuropeGilead SciencesGlaxoSmithKlineLetairisPharmaceuticalRegulationRespiratory and PulmonaryVolibris

FTC puts conditions on GSK/Novartis consumer JV

27-11-2014

The US Federal Trade Commission has voted to approve UK pharma giant GlaxoSmithKline’s proposed acquisition…

Dr Reddy's LaboratoriesGlaxoSmithKlineHabitrolMergers & AcquisitionsNicodermNovartisPharmaceuticalRegulationUSAVaccines

GlaxoSmithKline files for added Revolade indication in EU

12-11-2014

UK pharma major GlaxoSmithKline has filed an application with the European Medicines Agency for a variation…

EuropeGlaxoSmithKlineLigand PharmaceuticalsOncologyPharmaceuticalPromactaRare diseasesRegulationRevolade

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

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

NICE recommends another new skin cancer drug, GSK’s Tafinlar

22-10-2014

The UK National Institute for Health and Care Excellence (NICE) has issued final guidance recommending…

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationTafinlarUK

IQWiG finds no added benefit for GSK’s Anoro Ellipta in COPD

21-10-2014

According to the findings of an early benefit assessment under the German Act on the Reform of the Market…

Anoro ElliptaGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationRespiratory and Pulmonary

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

18-09-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft…

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationRocheTafinlarUKZelboraf

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

Amarin plunges as FDA denies appeal on ANCHOR trial SPA

14-09-2014

Shares of US biotech firm Amarin Corp tanked 23.7% to $1.38 on Friday in heavy trading, when the company…

AmarinCardio-vascularGlaxoSmithKlineLovazaPharmaceuticalRegulationVascepa

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

FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

ViiV Healthcare gains FDA approval for HIV drug Triumeq

ViiV Healthcare gains FDA approval for HIV drug Triumeq

23-08-2014

The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine…

Anti-viralsGlaxoSmithKlinePfizerPharmaceuticalRegulationShionogiTriumeqUSAViiV Healthcare

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

21-08-2014

UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has…

Arnuity ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUSA

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

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

GSK and Theravance submit US sNDA for Breo Ellipta in asthma

30-06-2014

US pharma giant GlaxoSmithKline and US partner Theravance have submitted a supplemental New Drug Application…

Breo ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUSA

IQWIG finds added benefit in adult patients for VIIV Healthcare’s Tivicay

27-05-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG),…

Anti-viralsGermanyGlaxoSmithKlinePharmaceuticalPricingRegulationTivicayViiV Healthcare

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

US FDA approves GSK’s Incruse Ellipta for COPD

US FDA approves GSK’s Incruse Ellipta for COPD

01-05-2014

The US Food and Drug Administration has approved UK pharma major GlaxoSmithKline’s Incruse (umeclidinium)…

Chronic lower respiratory diseasesCOPDGlaxoSmithKlineIncruseIncruse ElliptaMajorMedicinePharmaceuticalPulmonologyRegulationRespiratory and PulmonaryUKUSA

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

Canadian approval for GSK’s Incruse Ellipta as a treatment for COPD

17-04-2014

UK pharma giant GlaxoSmithKline says that Incruse Ellipta (umeclidinium) has received market authorization…

CanadaGlaxoSmithKlineIncruse ElliptaNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

1 to 25 of 147 results

Back to top