Regulation - Tresiba


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EC backs expanded approval of Novo Nordisk’s Tresiba for children

EC backs expanded approval of Novo Nordisk’s Tresiba for children


Danish diabetes care giant Novo Nordisk says that the European Commission has approved the expanded use…

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresiba

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

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


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

Label updates for Tresiba and Victoza backed by EMA committee


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

DiabetesEuropeNovo NordiskPharmaceuticalRegulationTresibaVictoza

Novo Nordisk files Tresiba/Victoza combo IDegLira for EU approval


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

DiabetesEuropeIDegLiraNovo NordiskPharmaceuticalRegulationTresibaVictoza

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


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


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

BexseroDiabetesEuropeNovartisNovo NordiskPharmaceuticalRegulationRyzodegTresibaVaccines

Novo Nordisk's Ryzodeg passes regulatory hurdle in Japan; diabetes burden review


Global insulin market leader Novo Nordisk (NOV: N) of Denmark revealed this morning that its Ryzodeg…

Asia-PacificDegludecDiabetesGlobalHealthcareNovo NordiskPharmaceuticalPricingRegulationRyzodegTresiba

Zealand Pharma valuation hinged on Lyxi/Lanti "fixflex"


The recent European Medicine Agency advisory committee, CHMP, positive opinion for French drug major…

BiotechnologyDiabetesFinancialLantusLyxumiaNovo NordiskRegulationResearchSanofiTresibaVictozaZealand Pharma

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


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


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


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

DegludecDiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

EMA panel backing for Novo Nordisk's Tresiba and Ryzodeg: Japanese review


The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday announced…

Asia-PacificDegludecDiabetesEuropeNovo NordiskPharmaceuticalRegulationRyzodegTresiba

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


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

DiabetesNorth AmericaNovo NordiskPharmaceuticalRegulationRyzodegTresiba

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