On January 8, 2019 the osteoporosis monoclonal antibody Evenity (romosozumab) developed by Amgen and UCB was granted approval by the Japanese Ministry of Health, Labor and Welfare for osteoporosis in patients at high risk of bone fracture.
Yesterday, Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced that 19 out of 20 members of the U.S. FDA, Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted YES for the approval of Evenity™ for osteoporosis in menopausal women with bone fracture. In their discussions, the committee emphasized the need for post . . .