Regulation - Novo Nordisk

Filter

Current filters:

Novo Nordisk

Popular Filters

1 to 25 of 47 results

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

The FDA publishes Novo Nordisk briefing documents ahead of Saxenda Advisory Committee meeting

09-09-2014

The US Food and Drug Administration has published briefing documents on Danish insulin giant Novo Nordisk’s…

Anti-diabetic drugsDiabetesliraglutideNovo NordiskPharmaceuticalRegulationTreatment of obesityUSA

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

Added benefit of Novo Nordisk’s Tresiba not proven, says IQWiG

08-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

DiabetesGerman Institute for Quality and EfficiencyGermanyNovo NordiskPharmaceuticalPricingRegulationTresiba

Novo Nordisk gains FDA backing for new NovoSeven RT indication

Novo Nordisk gains FDA backing for new NovoSeven RT indication

09-07-2014

Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa…

HematologyNovo NordiskNovoSevenNovoSeven RTPharmaceuticalRare diseasesRegulationUSA

IQWiG finds added benefit for Novo Nordisk’s NovoEight not proven

23-04-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

GermanyHematologyNorthern EuropeNovo NordiskNovoEightPharmaceuticalPricingRegulation

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

Label updates for Tresiba and Victoza backed by EMA committee

21-03-2014

The European Medicines agency’s Committee for Medicinal Products for Human Use has issued positive…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresibaVictoza

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

EMA Committee backs Novo Nordisk’s NovoRapid PumpCart

EMA Committee backs Novo Nordisk’s NovoRapid PumpCart

22-11-2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…

DiabetesEuropeNovo NordiskNovoRapidPharmaceuticalRegulationRoche

Novo Nordisk’s NovoEight passes first stage of Japanese approval

Novo Nordisk’s NovoEight passes first stage of Japanese approval

18-11-2013

Danish insulin giant Novo Nordisk’s recombinant factor VIII product NovoEight (turoctocog alfa) has…

Asia-PacificHematologyNovo NordiskNovoEightPharmaceuticalRare diseasesRegulation

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

Novo Nordisk recalls some NovoMix 30 insulin products in Europe

Novo Nordisk recalls some NovoMix 30 insulin products in Europe

27-10-2013

Danish insulin giant Novo Nordisk said on Friday that it is recalling certain batches of its prefilled…

DiabetesEuropeNovo NordiskNovoMixPharmaceuticalRegulation

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

Positive CHMP opinion for Novo Nordisk's NovoEight

Positive CHMP opinion for Novo Nordisk's NovoEight

20-09-2013

Danish insulin giant Novo Nordisk (NOV: N) revealed this morning that the European Medicines Agency’s…

EuropeNovo NordiskNovoEightPharmaceuticalRare diseasesRegulationturoctocog 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

Novo Nordisk files Tresiba/Victoza combo IDegLira for EU approval

31-05-2013

Danish insulin giant Novo Nordisk (NOV: N) said today (May 31) that it has submitted a marketing authorization…

DiabetesEuropeIDegLiraNovo NordiskPharmaceuticalRegulationTresibaVictoza

Briefs: Elan tender offer; German drug price review; Daiichi Sankyo pays milestone

19-04-2013

Ireland-based drugmaker Elan (NYSE: ELN) yesterday reported final results of its modified Dutch auction…

ActemraAmgenAnticalinBayerElanFinancialNovo NordiskPharmaceuticalPradaxaPricingProliaRegulationResearchRocheVictozaXarelto

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

EU approval for Novo Nordisk's Tresiba and Ryzodeg and for Novartis' for Bexsero

22-01-2013

Following positive recommendations from the European Medicines Agency's advisory committee, the European…

BexseroDiabetesEuropeNovartisNovo NordiskPharmaceuticalRegulationRyzodegTresibaVaccines

1 to 25 of 47 results

Back to top