Tag Archives: XGeva

January, 2018

5 January
FDA Approves Amgen’s Xgeva for Prevention of Skeletal-Related Events in Multiple Myeloma Patients

THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from …
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19 June
FDA Accepts Amgen’s sBLA to Expand Approval of Xgeva to Include Multiple Myeloma Patients

THOUSAND OAKS, Calif., June 19, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients …
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21 October
Amgen’s Xgeva Meets Primary Endpoint in Phase 3 Trial but Misses Secondary Endpoints

THOUSAND OAKS, Calif., Oct. 20, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that a Phase 3 study evaluating XGEVA® (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) in delaying the time to first on-study skeletal-related event (SRE) in …
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15 December
Amgen Reacquires Rights to Three Drugs from GSK

THOUSAND OAKS, Calif., Dec. 14, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that it has entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia® (denosumab), XGEVA®(denosumab) and Vectibix® (panitumumab) in 48 countries in Asia, South America, Europe, Australia and other regions throughout the world. …
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