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Hemolytic Uremic Syndrome News
FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris
INCHEON, South Korea, July 22, 2024 (GLOBE NEWSWIRE) – Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA)...
FDA Approves Bkemv (eculizumab-aeeb), an Interchangeable Biosimilar to Soliris
May 28, 2024 – Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is...
Alexion Receives FDA Approval for Ultomiris (ravulizumab-cwvz) for Atypical Hemolytic Uremic Syndrome (AHUS)
BOSTON October 18, 2019 --(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) approved Ultomiris (ravulizumab-cwvz) for the...
FDA Medwatch Alert: Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
ISSUE: Alexion Pharmaceuticals, Inc. announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30 mL concentrated solution for intravenous infusion. The...
Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
CHESHIRE, Conn.--(BUSINESS WIRE)--Sep 23, 2011 - Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Soliris® (eculizumab) for the treatment of ...