European drug regulator allows Novo to include reduction of kidney disease in Ozempic label
The European Medicines Agency (EMA) will allow Novo Nordisk to add risk reduction for events related to kidney disease to the label of its diabetes drug Ozempic, the Danish drugmaker said in a statement on Thursday.
Danish Regulators Flag Eye Risk for Novo’s Ozempic, Requesting EU Review
The Danish Medicines Agency had been watching reports of a rare eye disease in patients who took Novo’s GLP-1 drug but until now have declined to move forward with a more formal review. Two new studies have strengthened the link.
Novo Nordisk's Ozempic Gets CHMP's Positive Opinion To Include Kidney Disease Label Update
The decision was based on findings of the FLOW trial, which assessed the risk reduction from Ozempic therapy, a once-weekly subcutaneous semaglutide, in chronic kidney disease-related events. The randomized,
Europe allows Novo to include reduction of kidney disease in Ozempic label
The European Medicines Agency (EMA) will allow Novo Nordisk to add risk reduction for events related to kidney disease to the label of its diabetes drug Ozempic, the Danish drugmaker said in a statement on Thursday.
Novo Nordisk’s Ozempic Gets EU Regulator Endorsement to Reduce Kidney Risks
EU regulator supports a label expansion of Novo Nordisk’s diabetes drug to reflect its potential to lower the risk of conditions related to kidney disease in adults with Type 2 diabetes.
Ozempic Works on Kidney Disease, Regulator Says. Why Novo Nordisk Stock Is Falling.
Novo Nordisk's Ozempic will become the first and only GLP-1 drug to be shown to reduce progression of kidney disease in adults with Type 2 diabetes.
Novo Nordisk's Ozempic set to include kidney treatment label in EU
Novo Nordisk announced on Thursday that a key European Medicines Agency committee has backed a label update for weight-loss drug Ozempic to include the reduction of kidney disease risk. The decision was based on findings of a trial,
Novo Nordisk gets EMA nod for potential update of Ozempic label
Novo Nordisk (NVO) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an update of the Ozempic label to reflect data from the FLOW kidney outcomes trial.
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