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US Office of Generic Drugs reorganization

US Office of Generic Drugs reorganization

29-12-2013

The US Food and Drug Administration’s Center for Drug Evaluation and Research has approved plans to…

GenericsNorth AmericaRegulationUSA

Abbott Labs pays $5.5 million to settle claims it paid kickbacks to US physicians

Abbott Labs pays $5.5 million to settle claims it paid kickbacks to US physicians

29-12-2013

US drugmaker Abbott Laboratories has agreed to pay $5.475 million to resolve allegations that it violated…

LegalMarkets & MarketingNorth AmericaPharmaceuticalUSA

FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

24-12-2013

The US Food and Drug Administration yesterday (December 23) approved Tretten, coagulation factor XIII…

HematologyNorth AmericaNovo NordiskNovoThirteenPharmaceuticalRare diseasesRegulationTretten

Surprise US FDA approval for United Thera’s Orenitram ER for PAH

Surprise US FDA approval for United Thera’s Orenitram ER for PAH

23-12-2013

In what was seen by some observers as unexpected, the US Food and Drug Administration has approved United…

BiotechnologyNorth AmericaOrenitramRegulationRespiratory and PulmonaryTreprostinilUnited Therapeutics

FDA clears resumption of Iclusig sales in USA

FDA clears resumption of Iclusig sales in USA

22-12-2013

The US Food and Drug Administration has approved a revised US Prescribing Information and a Risk Evaluation…

North AmericaOncologyPharmaceuticalRegulation

Novo Nordisk files for approval of high strength liraglutide for obesity

Novo Nordisk files for approval of high strength liraglutide for obesity

22-12-2013

Danish insulin giant Novo Nordisk has filed separate regulatory submissions with the US Food and Drug…

DiabetesEuropeliraglutideMetabolicsNorth AmericaNovo NordiskPharmaceuticalRegulationVictoza

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

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