Pharmaceutical - Pharmaceutical, North America, GlaxoSmithKline

1 to 25 of 81 results

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 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

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

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

US patient share leaders in first-line BRAF-mutation positive malignant melanoma

27-11-2013

According to US oncologists surveyed in the third quarter of 2013 by BioTrends Research, a unit of Decision…

Bristol-Myers SquibbGlaxoSmithKlineMarkets & MarketingMekinistNorth AmericaOncologyPharmaceuticalRocheTafinlarYervoyZelboraf

US FDA clears GlaxoSmithKline’s H5N1 flu vaccine

26-11-2013

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s pandemic Influenza…

GlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US FDA eases restrictions on GSK diabetes drug Avandia

US FDA eases restrictions on GSK diabetes drug Avandia

26-11-2013

The US Food and Drug Administration yesterday (November 25) lifted some severe limitations on the prescribing…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

Pharma figures high in EU R&D Investment Scoreboard, but led by US firms

19-11-2013

Though not topping the league table, the pharmaceutical industry had a number of drugmakers among the…

EuropeFinancialGlaxoSmithKlineJohnson & JohnsonMerck & CoNorth AmericaNovartisPfizerPharmaceuticalResearchRocheSanofi

ViiV Healthcare’s Tivicay approved in Canada for HIV

04-11-2013

ViiV Healthcare, the HIV/AIDS joint venture set up by UK pharma giant GlaxoSmithKline with US behemoth…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

Theravance and GSK launch Breo Ellipta in USA

Theravance and GSK launch Breo Ellipta in USA

30-10-2013

GlaxoSmithKline and US partner Theravance today announced that Breo Ellipta for COPD is available to…

Breo ElliptaFinancialGlaxoSmithKlineMarkets & MarketingNorth AmericaPharmaceuticalRespiratory and PulmonaryTheravance

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

26-09-2013

The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing…

Anti-Arthritics/RheumaticsArzerraBiogen IdecGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRituxanRoche

US HHS replenishes nation's supply of anthrax antitoxin

20-09-2013

The USA’s supply of anthrax antitoxin will be maintained until 2018 under Project BioShield contracts…

Cangene CorpElusys TherapeuticsEmergent ProductsGlaxoSmithKlineHealthcareMarkets & MarketingNorth AmericaPharmaceuticalPharmAthene

US NIH trials flu vaccines from Sanofi and Novartis

US NIH trials flu vaccines from Sanofi and Novartis

19-09-2013

The US National Institutes of Health has begun testing an H7N9 avian influenza vaccine candidate in humans.

GlaxoSmithKlineHealthcareNorth AmericaNovartisPharmaceuticalSanofi PasteurVaccines

GlaxoSmithKline returns rights to vercirnon

19-09-2013

US drug developer ChemoCentryx (Nasdaq: CCXI) says that partner GlaxoSmithKline (LSE: GSK), the UK’s…

ChemoCentryxGastro-intestinalsGlaxoSmithKlineLicensingNorth AmericaPharmaceuticalvercirnon

GlaxoSmithKline, Community Care of North Carolina harness "small data" to improve patient care and reduce health care costs

18-09-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and Community Care of North Carolina (CCNC) today announced…

FinancialGlaxoSmithKlineHealthcareNorth AmericaPharmaceutical

Positive developments for GSK's Tafinlar/Mekinist and Arzerra

16-09-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has announced positive news relating to three of its drugs,…

ArzerraBiotechnologyGenmabGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlar

US Appeals Court reverses 2012 decision on Lovaza, clearing way for generics

13-09-2013

Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals…

AmarinCardio-vascularGenericsGlaxoSmithKlineLegalLovazaNorth AmericaPar PharmaceuticalsPatentsPharmaceuticalTeva Pharmaceutical IndustriesVascepa

AHF sues GSK for failing to provide discounts on HIV/AIDS drugs

11-09-2013

The USA-based AIDS Healthcare Foundation (AHF) said yesterday (September 10) that it has filed a law…

Anti-viralsGlaxoSmithKlineLegalNorth AmericaPharmaceuticalPricing

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

GSK's Flulaval vaccine approved by US FDA

16-08-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) has had its Flulaval quadrivalent intramuscular influenza…

FluarixFlulavalGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

FDA approves new ViiV Healthcare HIV drug

13-08-2013

The US Food and Drug Administration yesterday (August 12) approved Tivicay (dolutegravir), a new drug…

Anti-viralsdolutegravirGlaxoSmithKlineNorth AmericaPfizerPharmaceuticalRegulationShionogiTivicayViiV Healthcare

US FDA approves shipment of quadrivalent flu vaccine to health care providers

06-08-2013

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

US PDUFA for GSK diabetes drug delayed

03-08-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed on Friday (August 2) that the US Prescription Drug…

albiglutideDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

1 to 25 of 81 results

Back to top