FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events

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Go back to FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For Repatha® (evolocumab) To Include Data On Reducing Risk Of Cardiovascular Events

Amgen (AMGN) Reports Submission of Supplemental Biologics License Application For Prolia (denosumab)

July 31, 2017 9:12 AM EDT

Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia... More