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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

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

Novo Nordisk gains US FDA approval for FlexTouch insulin pens

Novo Nordisk gains US FDA approval for FlexTouch insulin pens

03-11-2013

Danish insulin giant Novo Nordisk announced on Friday that the US Food and Drug Administration has approved…

DiabetesFlexTouchLevemirNorth AmericaNovo NordiskNovoRapidPharmaceuticalRegulation

US FDA approved Novo Nordisk hemophilia A drug

US FDA approved Novo Nordisk hemophilia A drug

16-10-2013

Novo Nordisk revealed this morning that the US Food and Drug Administration has approved its Biologics…

HematologyNorth AmericaNovo NordiskNovoEightPharmaceuticalRegulationturoctocog alfa

Novo Nordisk makes US appointment; gets appro for NovoPen Echo

21-08-2013

Danish insulin giant Novo Nordisk (NOV: N) said late yesterday (August 21) that Jesper Hoiland has been…

DiabetesManagementNorth AmericaNovo NordiskNovoPen EchoPharmaceuticalRegulation

Tentative FDA clearance for generic copy of Novo Nordisk diabetes product

22-07-2013

US drugmaker Perrigo (Nasdaq: PRGO; TASE) says it has received tentative approval from the US Food &…

DiabetesGenericsNorth AmericaNovo NordiskPerrigoPrandinRegulation

Blow for Novo Nordisk, as FDA further delays Tresiba and Ryzodeg

11-02-2013

Danish insulin giant Novo Nordisk (NOV: N) revealed late Sunday that, on February 8, it received a Complete…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

FDA accepts Merck & Co's suvorexant; panel backs Novo's Tresiba and Ryzodeg

09-11-2012

US drug giant Merck & Co (NYSE: MRK) says that the New Drug Application for suvorexant, the company's…

DegludecDiabetesMerck & CoNeurologicalNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegsuvorexantTresiba

FDA briefing papers for Novo Nordisk's insulin degludec note need to review cardiac risks

06-11-2012

The US Food and Drug Administration yesterday published the briefing documents ahead of the Advisory…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

Novo Nordisk says US FDA advisory panel to focus on degludec cardiovascular safety

26-10-2012

Denmark-based insulin giant Novo Nordisk (NOV: N) late yesterday announced that the US Food and Drug…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

Novo Nordisk files hemophilia drug turoctocog in USA and EU

17-10-2012

Denmark's Novo Nordisk (NOV: N), the world's largest insulin maker, has submitted regulatory application…

EuropeNorth AmericaNovo NordiskPharmaceuticalRare diseasesRegulationturoctocog alfa

FDA further delays Novo Nordisk's ultra long-acting insulin products Tresiba and Ryzodeg

19-07-2012

Denmark's Novo Nordisk (NOV: N), the world's largest insulin maker, says that the US Food and Drug Administration…

DiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

US FDA delays approval of Novo Nordisk's ultra-long acting insulins

08-06-2012

The US Food and Drug Administration has extended the regulatory review period for the ultra-long-acting…

DegludecDegludecPlusDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulation

FDA expands Levemir use to young children; negative on tafamidis

23-05-2012

Denmark-based global insulin giant Novo Nordisk (NOV: N) says that the US Food and Drug Administration…

DiabetesLevemirNorth AmericaNovo NordiskPfizerPharmaceuticalRare diseasesRegulationtafamidisVyndaqel

Positive Ph III results for Novo Nordisk's degludec; US advocacy calls for Victoza's withdrawal

23-04-2012

Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin…

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

Victoza US label update includes superior efficacy over Januvia, says Novo Nordisk

10-04-2012

The US Food and Drug Administration has approved an update to the product label for Victoza (liraglutide…

DiabetesJanuviaLevemirMerck & CoNorth AmericaNovo NordiskPharmaceuticalRegulationResearchVictoza

FDA OKs pregnancy use of Novo Nordisk diabetes therapy Levemir

02-04-2012

The US Food and Drug Administration has approved Levemir (insulin detemir [rDNA origin] injection), from…

DiabetesLevemirNorth AmericaNovo NordiskPharmaceuticalRegulation

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