Regulation - GlaxoSmithKline, North America

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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 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

Sarepta plunges as FDA questions eteplirsen trial results

Sarepta plunges as FDA questions eteplirsen trial results

12-11-2013

Shares of US RNA-based drug developer Sarepta Therapeutics plummeted in pre-market trading on November…

BiotechnologydrisaperseneteplirsenGlaxoSmithKlineNorth AmericaRare diseasesRegulationResearchSarepta Therapeutics

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

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

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

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

Mylan cleared to sell generic Wellbutrin XL in USA

26-08-2013

There was good news last week for US specialty and generics company Mylan (Nasdaq: MYL), when the US…

GenericsGlaxoSmithKlineMylan LaboratoriesNeurologicalNorth AmericaRegulationWellbutrin XL

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

GlaxoSmithKline files sNDAs for combination melanoma drugs

09-07-2013

UK pharma giant GlaxoSmithKline (LSE: GSK) said today (July 9) that it has submitted supplemental New…

BiotechnologyGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlar

FDA backs Baxter's Rixubis for hemophilia B; Breakthrough status for GSK's drisapersen

28-06-2013

The US Food and Drug Administration yesterday (June 27) approved Baxter International's (NYSE: BAX) Rixubis…

Baxter InternationaldrisapersenGlaxoSmithKlineNorth AmericaPharmaceuticalRare diseasesRegulationRixubis

Majority vote from FDA advisory panel to ease restrictions on GSK's Avandia

07-06-2013

A joint advisory committee to the US Food and Drug Administration (FDA) voted to continue to make UK…

AvandiaDiabetesGlaxoSmithKlineNorth AmericaPharmaceuticalRegulation

FDA approves two GSK melanoma drugs and bioMerieux companion diagnostic

30-05-2013

The US Food and Drug Administration yesterday (May 29) approved two new oral drugs from UK pharma giant…

BioMerieuxdabrafenibGlaxoSmithKlineMekinistNorth AmericaOncologyPharmaceuticalRegulationTafinlartrametinib

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

J&J's daratumumab gets "Breakthrough" status; GSK's trametinib delayed by FDA

02-05-2013

The US Food and Drug Administration has granted "Breakthrough Therapy Designation" for health care giant…

daratumumabGenmabGlaxoSmithKlineJanssenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalRegulationtrametinib

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

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