Regulation - GlaxoSmithKline, USA

Filter

Current filters:

GlaxoSmithKlineUSA

Popular Filters

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

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 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

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

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

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 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 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

Parexel

Parexel

Back to top