Amgen (AMGN), UCB Announce FDA Acceptance of BLA For Romosozumab
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Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
September 26, 2016 4:00 PM EDTTHOUSAND OAKS, Calif. and BRUSSELS, Sept. 26, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.
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