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Novo Nordisk

 •  August 28

Victoza® reduces the risk of major cardiovascular events in people with type 2 diabetes with or without prior events Barcelona, Spain, 28 August 2017 - A new analysis of the landmark LEADER trial shows that Victoza® (liraglutide) reduced the risk of major cardiovascular (CV) events in people with type 2 diabetes at high CV risk, irrespective of...

Novo Nordisk

 •  July 27

Novo Nordisk A/S: Victoza® has been approved in the EU as the only GLP-1 with a label to include prevention of cardiovascular events Bagsværd, Denmark, 27 July 2017 - The European Commission has approved an update to the Victoza® (liraglutide) EU label that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events...

Novo Nordisk

 •  June 16

FDA posts briefing materials prior to Advisory Committee meeting for Victoza® label update Bagsværd, Denmark, 16 June 2017 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss the supplemental New Drug Application (sNDA) for approval of...

Novo Nordisk

 •  March 27

Fiasp®, a new, ultra-fast acting mealtime insulin is available for the treatment of diabetes in adults Canada first country to launch Fiasp® Bagsværd, Denmark, 27 March 2017 ­­­- Today, Novo Nordisk announced that Fiasp®, a new, fast-acting mealtime insulin for the treatment of diabetes in adults, has been launched in Canada, following the recent...

Novo Nordisk

 •  December 5, 2016

Novo Nordisk files for regulatory approval of once-weekly semaglutide in the US and EU for the treatment of type 2 diabetes Bagsværd, Denmark, 5 December 2016 - Novo Nordisk today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European...

Novo Nordisk

 •  November 29, 2016

Novo Nordisk A/S: Tresiba® demonstrates a safe cardiovascular profile and reduces the risk of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial Bagsværd, 29 November 2016 - Today, Novo Nordisk announced the headline results from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to...

Novo Nordisk

 •  November 21, 2016

Novo Nordisk receives US FDA approval for Xultophy® 100/3.6 Bagsværd, Denmark, 21 November 2016 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Xultophy® 100/3.6. Xultophy® 100/3.6 is indicated as an adjunct to diet and exercise to improve glycaemic control in adults...

Novo Nordisk

 •  November 1, 2016

New data show post-meal hyperglycaemia is associated with a negative impact on quality of life for people with diabetes Vienna, Austria, 1 November 2016 ­- New data from the first health-related quality of life (HRQL) study related to post-meal or postprandial glucose (PPG) control, show that poor PPG control has a significant negative impact on...

Novo Nordisk

 •  October 25, 2016

Novo Nordisk submits application to regulatory authorities to include LEADER data in Victoza® label Bagsværd, Denmark, 25 October 2016 - Novo Nordisk today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) and a Type II Variation application to the European Medicines Agency (EMA)...

Novo Nordisk

 •  September 16, 2016

Semaglutide reduced major cardiovascular events by 26% in adults with type 2 diabetes at high cardiovascular risk Munich, Germany, 16 September 2016 - Novo Nordisk today announced that semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, significantly reduced the risk of the primary composite endpoint...