Paroxysmal Nocturnal Hemoglobinuria

• FDA approval · 2024-06-20
  FDA Approved: PIASKY — Original Application (Genentech, Inc.)

  The FDA approved PIASKY (crovalimab) from Genentech via an original BLA, marking its first regulatory approval as a new monoclonal antibody …

• 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 · 2024-03-29
  FDA Approved: VOYDEYA — Original Application (Alexion Pharmaceuticals Inc.)

  FDA approved VOYDEYA (danicopan) from Alexion Pharmaceuticals as an oral Factor D inhibitor for adults with paroxysmal nocturnal hemoglobinu…

• FDA approval · 2024-02-08
  FDA Approved: EMPAVELI — Supplemental Application (Apellis Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EMPAVELI (pegcetacoplan) from Apellis Pharmaceuticals, Inc. to update the product labeling.

• FDA approval · 2023-09-28
  FDA Approved: EMPAVELI — Supplemental Application (Apellis Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EMPAVELI (pegcetacoplan) submitted by Apellis Pharmaceuticals. This action updates the produ…

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• FDA approval · 2023-02-08
  FDA Approved: EMPAVELI — Supplemental Application (Apellis Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EMPAVELI (pegcetacoplan) submitted by Apellis Pharmaceuticals, Inc., resulting in updated la…

• 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 · 2021-05-14
  FDA Approved: EMPAVELI — Original Application (Apellis Pharmaceuticals, Inc.)

  The FDA approved EMPAVELI (pegcetacoplan) from Apellis Pharmaceuticals as a treatment for adults with paroxysmal nocturnal hemoglobinuria wh…

• 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…

• CLINICAL_TRIALS approval · 2014-05-06
  Clinical Trial Update: The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

  Marketing approval has been granted for eculizumab as a treatment for paroxysmal nocturnal hemoglobinuria under the sponsor's early access t…

• 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…