Atypical Hemolytic Uremic Syndrome

• FDA approval · 2026-03-26
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen.

• FDA approval · 2025-11-24
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, a biosimilar to eculizumab.

• FDA approval · 2025-09-02
  FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for EPYSQLI (eculizumab-aagh) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-03-12
  FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for EPYSQLI (eculizumab-aagh), a biosimilar to eculizumab.

• FDA approval · 2025-01-30
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  FDA approved BKEMV (eculizumab-aeeb) under Amgen’s supplemental application, making a biosimilar to eculizumab available. The product is int…

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• FDA approval · 2024-10-23
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, updating its labeling and indications for this eculizuma…

• FDA approval · 2024-09-19
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals, resulting in updated labeling that ma…

• FDA approval · 2024-07-19
  FDA Approved: EPYSQLI — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved EPYSQLI (eculizumab-aagh) from Teva as a biosimilar to Soliris, for the same indications as the reference product.

• FDA approval · 2024-05-28
  FDA Approved: BKEMV — Original Application (Amgen Inc)

  FDA approved BKEMV (eculizumab-aeeB), a biosimilar to eculizumab, developed by Amgen. The approval covers the same indications as the refere…

• FDA approval · 2021-06-07
  FDA Approved: ULTOMIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  FDA approved a supplemental application for ULTOMIRIS (ravulizumab) from Alexion Pharmaceuticals, reflecting an update to labeling or expans…

• FDA approval · 2020-10-09
  FDA Approved: ULTOMIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Ultomiris (ravulizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the la…

• FDA approval · 2019-06-27
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals Inc., updating labeling to reflect the…

• FDA approval · 2018-12-21
  FDA Approved: ULTOMIRIS — Original Application (Alexion Pharmaceuticals Inc.)

  FDA approved Ultomiris (ravulizumab) through the original application for treatment of certain complement-mediated diseases, including parox…

• FDA approval · 2012-12-21
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  FDA approved a supplemental application for SOLIRIS (eculizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the product l…