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Eculizumab News
Monthly News Roundup - May 2024
FDA Clears GSK’s Benlysta Autoinjector for Systemic Lupus Erythematosus (SLE) in Children In May, the U.S Food and Drug Administration (FDA) cleared GSK’s Benlysta subcutaneous autoinjector (given as ...
Monthly News Roundup - May 2024
FDA Clears GSK’s Benlysta Autoinjector for Systemic Lupus Erythematosus (SLE) in Children In May, the U.S Food and Drug Administration (FDA) cleared GSK’s Benlysta subcutaneous autoinjector (given as ...
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 of Soliris (eculizumab) for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder
BOSTON--(BUSINESS WIRE)--June 27, 2019 – Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Soliris (eculizumab) for the treatment of...
FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (GMG)
NEW HAVEN, Conn.--(BUSINESS WIRE) October 23, 2017 --Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab) as...
FDA Medwatch Alert: Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles
ISSUE: Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion....
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 ...
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