Finerenone reduced the incidence of the primary composite endpoint of CV death, nonfatal MI ... principal investigator of FIDELIO-DKD. “This label update reaffirms Kerendia as a fundamental ...

label to include a reduction in the risk of heart attack, stroke, or CV death in adults with type 2 diabetes and established CV disease. Canagliflozin, an oral SGLT2 inhibitor, thus becomes the ...

In the FDA briefing, Sharretts also outlined a number of label possibilities that should cheer Amarin shareholders, including treating patients with established CV disease or expanding treatment ...

Back to Healio The FDA issued a draft guidance recommending that labels of over-the-counter aspirin using any CV-related imagery be accompanied by a statement reminding consumers to speak to a ...

to Tresiba’s label. And if Novo can snag an OK, it’ll help level the playing field against its competition. RELATED: Novo's Tresiba matches Sanofi rival Lantus in CV safety study—and cuts ...