Paroxysmal Nocturnal Hemoglobinuria
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EMA approval · 2026-08-07EMA Authorised: Epysqli (Eculizumab) — Samsung Bioepis NL B.V.
Epilishi (Eculizumab) from Samsung Bioepis NL B.V. has been authorised by EMA for its indicated use in paroxysmal nocturnal hemoglobinuria.
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EMA approval · 2026-07-31EMA Authorised: Aspaveli (pegcetacoplan) — Swedish Orphan Biovitrum AB (publ)
Aspaveli (pegcetacoplan) by Swedish Orphan Biovitrum AB has been authorised by the EMA for paroxysmal nocturnal hemoglobinuria (PNH).
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EMA approval · 2026-07-21EMA Authorised: Ultomiris (ravulizumab) — Alexion Europe SAS
EMA authorises Ultomiris (ravulizumab) for paroxysmal hemoglobinuria (PNH), with Alexion Europe SAS as the marketing authorisation holder.
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EMA approval · 2026-06-09EMA Authorised: Ultomiris (ravulizumab) — Alexion Europe SAS
The European Medicines Agency authorised Ultomiris (ravulizumab) for its indicated use under the owner Alexion Europe SAS, with decision dat…
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FDA approval · 2026-03-26FDA Approved: BKEMV — Supplemental Application (Amgen Inc)
FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen.
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EMA approval · 2026-02-19EMA Authorised: Soliris (Eculizumab) — Alexion Europe SAS
The EMA authorised Soliris (eculizumab) in the European Union for paroxysmal nocturnal hemoglobinuria. The decision carries orphan medicine …
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EMA approval · 2026-02-18EMA Authorised: Epysqli (Eculizumab) — Samsung Bioepis NL B.V.
EMA authorised Epysqli, a biosimilar of eculizumab, by Samsung Bioepis NL B.V., for paroxysmal nocturnal hemoglobinuria.
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EMA approval · 2026-02-10EMA Authorised: Piasky (Crovalimab) — Roche Registration GmbH
The European Medicines Agency authorised Piasky (crovalimab) by Roche Registration GmbH for the treatment of paroxysmal nocturnal hemoglobin…
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EMA approval · 2026-01-26EMA Authorised: Aspaveli (pegcetacoplan) — Swedish Orphan Biovitrum AB (publ)
The European Medicines Agency authorised Aspaveli (pegcetacoplan) by Swedish Orphan Biovitrum AB (publ) for the treatment of paroxysmal noct…
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EMA approval · 2026-01-15EMA Authorised: Bekemv (Eculizumab) — Amgen Technology (Ireland) UC
The EMA authorised Bekemv (eculizumab) from Amgen Technology (Ireland) UC for paroxysmal nocturnal hemoglobinuria.
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EMA approval · 2026-01-13EMA Authorised: Voydeya (danicopan) — Alexion Europe SAS
The European Medicines Agency authorised Voydeya (danicopan) for paroxysmal nocturnal hemoglobinuria, designated as an orphan medicine, with…
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EMA approval · 2025-12-19EMA Authorised: Fabhalta (iptacopan hydrochloride monohydrate) — Novartis Europharm Limited
The European Medicines Agency authorized Fabhalta (iptacopan hydrochloride monohydrate) from Novartis Europharm Limited for paroxysmal noctu…
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FDA approval · 2025-11-24FDA Approved: BKEMV — Supplemental Application (Amgen Inc)
The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, a biosimilar to eculizumab.
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EMA approval · 2025-10-22EMA Authorised: Ultomiris (ravulizumab) — Alexion Europe SAS
The European Medicines Agency authorised Ultomiris (ravulizumab) for paroxysmal nocturnal hemoglobinuria, under the responsibility of Alexio…
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FDA approval · 2025-09-02FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves a supplemental application for EPYSQLI (eculizumab-aagh) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2025-07-28FDA Approved: EMPAVELI — Supplemental Application (Apellis Pharmaceuticals, Inc.)
FDA approved a supplemental application for EMPAVELI (pegcetacoplan) from Apellis Pharmaceuticals.
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FDA approval · 2025-06-27FDA Approved: VOYDEYA — Supplemental Application (Alexion Pharmaceuticals Inc.)
FDA approved a supplemental application for VOYDEYA (danicopan) by Alexion Pharmaceuticals to treat paroxysmal nocturnal hemoglobinuria.
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FDA approval · 2025-06-10FDA Approved: EMPAVELI — Supplemental Application (Apellis Pharmaceuticals, Inc.)
The FDA approved a supplemental application for EMPAVELI (pegcetacoplan) from Apellis Pharmaceuticals.
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FDA approval · 2025-05-14FDA Approved: PIASKY — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for PIASKY (crovalimab) from Genentech, Inc., resulting in an updated labeling per the approval.
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FDA approval · 2025-03-12FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for EPYSQLI (eculizumab-aagh), a biosimilar to eculizumab.
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FDA approval · 2025-01-30FDA 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 · 2024-10-23FDA 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…
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FDA approval · 2024-10-07FDA Approved: EMPAVELI — Supplemental Application (Apellis Pharmaceuticals, Inc.)
FDA approved a supplemental application for EMPAVELI (pegcetacoplan) submitted by Apellis Pharmaceuticals, Inc.
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FDA approval · 2024-09-19FDA 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…
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FDA approval · 2024-07-19FDA 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.