Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on review transparency for new molecular entity NDAs and BLAs.
Federal Register Notice; FDA debars David Freeman for five years from providing services to anyone with an approved or pending drug product application.
Amgen reports that its Phase 3 ASPECCT trial of Vectibix vs. Erbitux as a single agent for treating chemorefractory metastatic colorectal cancer in patients with wild-type KRAS tumors, met its primary endpoint.