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FDA Accepts Amgens Submission and Files Biologics License Application for Denosumab
Amgen, 02/19/09
Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer.
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