Tag Archives: Repatha

November, 2018

July, 2017

  • 28 July

    FDA Grants Priority Review for Amgen’s sBLA for Repatha

    THOUSAND OAKS, Calif., July 27, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen’s supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will …

March, 2017

July, 2016

  • 11 July

    FDA Approves Amgen’s Single Monthly Injection for a PCSK9 Inhibitor

    THOUSAND OAKS, Calif., July 11, 2016 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1 The Pushtronex system is a hands-free device designed to provide 420 …

May, 2016

August, 2015

  • 28 August

    FDA Approves Amgen’s PCSK9 Inhibitor Repatha

    The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to …