BioSpace1d
Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which ...
FiercePharma1d
Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide
“Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective ...
Novo Nordisk asks FDA to block compounding pharmacies from making Ozempic copycats
Novo Nordisk wants the Food and Drug Administration (FDA) to prevent compounding pharmacies from manufacturing their own ...
STAT2d
Novo asks FDA to bar compounders from making Ozempic copies
The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...
FiercePharma3d
Novo plots US, EU approval filings after oral semaglutide shows cardio benefits in certain diabetes patients
As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the ...
GlobalData on MSN2d
Novo Nordisk plans label expansion for Rybelsus following Phase III win
The oral semaglutide reduced the occurrence of major adverse cardiovascular events (MACE) by 14% in patients with type 2 ...