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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

GSK confirms further misconduct allegations, now in Jordan and Lebanon

17-04-2014

There has been recent publicity on cases of alleged misconduct by UK Pharma giant GlaxoSmithKline employees…

GlaxoSmithKlineJordanMarkets & MarketingPharmaceuticalRegulationRest of the World

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

FDA finally OKs GlaxoSmithKline’s Tanzeum to treat type 2 diabetes

16-04-2014

UK pharma giant GlaxoSmithKline yesterday received the much anticipated approval from the US Food and…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationTanzeumUSA

GSK’s Tafinlar also no added benefit over vemurafenib, says IQWiG

GSK’s Tafinlar also no added benefit over vemurafenib, says IQWiG

09-04-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

GermanyGlaxoSmithKlineNorthern EuropeOncologyPharmaceuticalPricingRegulationTafinlarvemurafenib

Teva launches first generic Lovaza in USA

Teva launches first generic Lovaza in USA

08-04-2014

Israel-based Teva Pharmaceutical Industries says it has received US Food and Drug Administration approval…

Cardio-vascularGenericsGlaxoSmithKlineLovazaMarkets & MarketingRegulationTeva Pharmaceutical IndustriesUSA

GSK faces fresh allegations of “inproper conduct” in Iraq

GSK faces fresh allegations of “inproper conduct” in Iraq

08-04-2014

UK pharma major GlaxoSmithKline is facing allegations of bribery in Iraq, less than a year after the…

ChinaGlaxoSmithKlineGSKIraqMajorPharmaceuticalRegulationUK

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

GSK withdraws European marketing authorization for ovarian cancer drug Votrient

31-03-2014

UK pharma major GlaxoSmithKline has withdrawn its application to the European Medicines Agency for a…

GlaxoSmithKlineOncologyPharmaceuticalRegulationUKVotrientWomen's Health

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

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

GSK receives positive CHMP opinion for COPD drug Incruse

GSK receives positive CHMP opinion for COPD drug Incruse

21-02-2014

GlaxoSmithKline has announced that the European Medicines Agency’s Committee for Medicinal Products…

GlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUKumeclidinium

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

GSK and Theravance’s Anoro gets positive EMA panel backing for COPD

21-02-2014

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

Anoro ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance Biopharma

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

03-02-2014

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for UK pharma…

GlaxoSmithKlinePharmaceuticalPromactaRare diseasesRegulationRevolade

Positive EMA/CHMP opinion for GlaxoSmithKline’s diabetes drug Eperzan

Positive EMA/CHMP opinion for GlaxoSmithKline’s diabetes drug Eperzan

24-01-2014

Among a batch of positive opinions issued today by the European Medicines Agency’ s Committee for Medicinal…

DiabetesEperzanGlaxoSmithKlinePharmaceuticalRegulation

GSK gains accelerated FDA approval for combination use of Mekinist and Tafinlar

GSK gains accelerated FDA approval for combination use of Mekinist and Tafinlar

09-01-2014

GlaxoSmithKline (LSE: GSK) says that the US Food and Drug Administration has approved Mekinist (trametinib)…

GlaxoSmithKlineMekinistOncologyPharmaceuticalRegulationTafinlarUKUSA

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