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Romosozumab Approval Status

Romosozumab is an anti-sclerostin monoclonal antibody in development for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Development Status and FDA Approval Process for romosozumab

DateArticle
Nov 12, 2016Results From Phase 3 BRIDGE Study Show Romosozumab Significantly Increases Bone Mineral Density In Men With Osteoporosis
Sep 26, 2016Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
Sep 18, 2016Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis
Jul 21, 2016Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA
Mar 20, 2016Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis
Feb 21, 2016Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis
Oct 12, 2015New Exploratory Analysis Showed Romosozumab Increased Estimated Bone Strength More Than Teriparatide
Sep  1, 2015Amgen And UCB Announce Positive Top-Line Results From Open-Label Phase 3 Study Of Romosozumab Compared With Teriparatide

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