FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book.
FDA approves Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patients with renal cell carcinoma.
FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book.
FDA approves Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patients with renal cell carcinoma.
A just-posted notice from Amgen outlines the basis for the company's defense of why its ANCA-associated vasculitis drug Tavneos should not be withdrawn from the market.
Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer failed to meet its primary endpoint of overall survival.
