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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

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

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 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

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

19-12-2013

The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

Relvar Ellipta approved for asthma and COPD in Europe

Relvar Ellipta approved for asthma and COPD in Europe

19-11-2013

The European Commission has granted marketing authorization for Relvar Ellipta (fluticasone furoate/vilanterol…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRelvar ElliptaRespiratory and PulmonaryTheravance

Positive CHMP recommendation for Relvar Ellipta

20-09-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) announced that the…

EuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance

Japanese approvals for GSK, Kyorin/Skyepharma, Novartis/Vectura and Takeda

20-09-2013

UK pharma major GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) has announced that…

Asia-PacificFlutiformGlaxoSmithKlineKyorin PharmaceuticalsMetabolicsNovartisObleanPharmaceuticalRegulationRelvarRespiratory and PulmonarySkyepharmaTakeda PharmaceuticalsUltibro BreezhalerVectura

FDA advisory panel gives thumbs up for Anoro Ellipta approval

11-09-2013

There was a bit of good news for UK pharma giant GlaxoSmithKline yesterday (LSE: GSK) and partner USA-based…

Anoro ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

GSK's Anoro Ellipta shows efficacy in COPD, say FDA briefing papers

09-09-2013

UK drug major GlaxoSmithKline's (LSE: GSK) Anoro Ellipta (vilanterol/umeclidinium) to treat chronic obstructive…

Anoro ElliptaBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

GlaxoSmithKline and Theravance withdraw Japan NDA for Relvar Ellipta in COPD

12-07-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) revealed on Friday…

Asia-PacificBiotechnologyGlaxoSmithKlinePharmaceuticalRegulationRelvar ElliptaRespiratory and PulmonaryTheravance

FDA approves Theravance and GSK's Breo Ellipta to treat COPD

13-05-2013

The US Food and Drug Administration on Friday (May 10) approved Breo Ellipta (fluticasone furoate, an…

BiotechnologyBreo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySkyepharmaTheravance Biopharma

GlaxoSmithKline files for umeclidinium monotherapy approval in Europe

29-04-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has submitted a regulatory application in the European Union…

BiotechnologyEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceumeclidinium

GlaxoSmithKline and Theravance file for Japanese approval of Anoro Ellipta

22-04-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) today April 22) announced…

Anoro ElliptaAsia-PacificGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravance

FDA advisory panel backs approval of COPD drug Breo Ellipta

18-04-2013

Having earlier this week been presented with ambivalent briefing papers, the US Food and Drug Administration's…

Breo ElliptaGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTheravance

USA FDA seeks clarification on Discovery Labs' Surfaxin; issues briefing papers on GSK's Breo Ellipta

15-04-2013

US biotech firm Discovery Laboratories (Nasdaq: DSCO) says that the Food and Drug Administration has…

Breo ElliptaDiscovery LaboratoriesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxinTheravance

Regulatory updates for Tris Pharma's Karbinal; GSK's four-strain seasonal flu vaccine

03-04-2013

US drug delivery specialist Tris Pharma says that the US Food and Drug Administration has approved its…

Anti-viralsEuropeFluarixGlaxoSmithKlineInflusplit TetraKarbinalNorth AmericaPharmaceuticalRegulationRespiratory and PulmonaryTris Pharma

Positive NICE news for GSK's Revolade and InterMune's Esbriet

21-03-2013

UK drugs watchdog the National Institute for Health and Clinical Excellence today (March 21) issued two…

BiotechnologyEsbrietEuropeGlaxoSmithKlineImmunologicalsInterMunePharmaceuticalPricingRegulationRespiratory and PulmonaryRevolade

GlaxoSmithKline and Theravance file for EU approval of UMEC/VI for COPD

10-01-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) yesterday submitted…

AnoroBiotechnologyEuropeGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryTheravanceUMEC/VIumeclidiniumvilanterol

News briefs from Sanofi, Bayer, GlaxoSmithKline and Novartis

21-12-2012

French drug major Sanofi (Euronext: SAN) has entered into a binding agreement to acquire the animal health…

BayerDosch PharmaceuticalsExjadeFlonaseGlaxoSmithKlineLegalMergers & AcquisitionsMerialNovartisOncologyPharmaceuticalregorafenibRegulationRespiratory and PulmonarySanofi

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