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FDA issues Complete Response Letter for once weekly basal insulin icodec – Novo Nordisk

Written by | 16 Jul 2024

Novo Nordisk announced that the FDA has issued a Complete Response Letter covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus…. read more.

Risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients prescribed semaglutide – Novo Nordisk

Written by | 12 Jul 2024

A new observational study reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision… read more.

Wegovy (semaglutide) is approved by NMPA (China) for long-term weight management for overweight and obese people – Novo Nordisk

Written by | 30 Jun 2024

Novo Nordisk’s weight-loss drug Wegovy has been approved for sale in China, opening the door to a huge market in which obesity rates have more than doubled among… read more.

CHMP positive recommendation for dasiglucagon for treatment of severe hypoglycemia in diabetes – Zealand Pharma A/S + Novo Nordisk

Written by | 7 Jun 2024

Zealand Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing… read more.

Four year data for Wegovy (semaglutide) in obesity presented at ECO meeting and published in Nature – Novo Nordisk

Written by | 18 May 2024

At the European Congress on Obesity in Venice, investigators unveiled results from an analysis published in Nature Medicine evaluating Wegovy’s weight loss benefits over four years. With this… read more.

Wegovy approved in the US for cardiovascular risk reduction in people with overweight or obesity and established cardiovascular disease – Novo Nordisk

Written by | 14 Mar 2024

Novo Nordisk announced that the FDA has approved a label expansion for Wegovy based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of… read more.

MAA submitted to the European Medicines Agency for dasiglucagon for treatment of severe hypoglycemia in diabetes – Novo Nordisk + Zealand Pharma

Written by | 1 Jul 2023

Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European… read more.

CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

Written by | 30 Jun 2023

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Refixia…. read more.

Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity – Novo Nordisk

Written by | 14 Dec 2021

Results from the STEP 5 phase IIIb trial, presented by Novo Nordisk at the Obesity Week 2021 interactive congress, showed that adults treated with Wegovy (semaglutide 2.4 mg… read more.

Investigational 2.0 mg dose of once weekly Ozempic demonstrates superior reductions in blood sugar vs Ozempic 1.0 mg in type II diabetes – Novo Nordisk

Written by | 4 Jul 2021

Novo Nordisk presented data showing that an investigational 2.0 mg dose of Ozempic (semaglutide) provided statistically significant and superior reductions in blood sugar (HbA1C) compared with Ozempic 1.0… read more.

CHMP recommends expanded approval for Saxenda in obesity – Novo Nordisk

Written by | 7 Apr 2021

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda (liraglutide) is… read more.

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