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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

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

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

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

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

Regulatory updates on GSK's albiglutide, Roche's hep C test, Activartis AV0113

07-03-2013

UK pharma giant GlaxoSmithKline plc (LSE: GSK) says it has submitted a Marketing Authorization Application…

ActivartisalbiglutideAnti-viralsAV0113BiotechnologyDiabetesEperzanEuropeGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRoche

Pfizer's Quillivant XR oral suspension now available in USA; GlaxoSmithKline files BLA for albiglutide

15-01-2013

Confirming expectations announced when Pfizer (NYSE: PFE) revealed its $680 million acquisition of NextWave…

albiglutideDiabetesGlaxoSmithKlineMarkets & MarketingNeurologicalNorth AmericaPfizerPharmaceuticalQuillivantRegulation

GlaxoSmithKline readies for filing of diabetes drug albiglutide on positive final data

12-07-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) says that positive data from the Phase III Harmony 8 study…

albiglutideDiabetesGlaxoSmithKlineJanuviaMerck & CoPharmaceuticalRegulationResearch

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