Beta-thalassemia

• EMA approval · 2026-06-12
  EMA Authorised: Deferasirox Mylan (deferasirox) — Mylan Pharmaceuticals Limited

  The EMA has authorised Deferasirox Mylan for iron overload indications, including beta-thalassemia, with Mylan Pharmaceuticals Limited as th…

• EMA approval · 2026-04-21
  EMA Authorised: Ferriprox (Deferiprone) — Chiesi Farmaceutici S.p.A.

  The European Medicines Agency authorised Ferriprox (deferiprone) from Chiesi Farmaceutici S.p.A. for the treatment of beta-thalassemia and i…

• EMA approval · 2026-02-19
  EMA Authorised: Casgevy (Exagamglogene autotemcel) — Vertex Pharmaceuticals (Ireland) Limited

  EMA authorised Casgevy (exagamglogene autotemcel) by Vertex for beta-thalassemia and sickle cell disease, with conditional approval and orph…

• EMA approval · 2026-02-05
  EMA Authorised: Exjade (deferasirox) — Novartis Europharm Limited

  The EMA authorised Exjade (deferasirox) by Novartis Europharm Limited for beta-thalassemia and iron overload in the European Union.

• EMA approval · 2025-11-24
  EMA Authorised: Reblozyl (Luspatercept) — Bristol Myers Squibb Pharma EEIG

  The European Medicines Agency authorised Reblozyl (luspatercept) by Bristol Myers Squibb Pharma EEIG for treating anemia associated with bet…

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• FDA approval · 2025-10-21
  FDA Approved: DEFERASIROX — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Deferasirox from Actavis Pharma, Inc. This action updates the regulatory status of the product.

• EMA approval · 2025-09-30
  EMA Authorised: Deferasirox Accord (deferasirox) — Accord Healthcare S.L.U.

  The EMA authorised Deferasirox Accord (deferasirox) for treating iron overload and beta-thalassemia.

• EMA approval · 2025-09-29
  EMA Authorised: Deferasirox Mylan (deferasirox) — Mylan Pharmaceuticals Limited

  EMA has authorised Deferasirox Mylan (deferasirox) for treatment of iron overload, including in patients with beta-thalassemia. This marks E…

• EMA approval · 2023-12-15
  First gene editing therapy to treat beta thalassemia and severe sickle cell disease

  EMA recommended approval of Casgevy, the first gene-editing therapy using CRISPR/Cas9 for transfusion-dependent beta-thalassemia and severe …

• FDA approval · 2023-08-28
  FDA Approved: REBLOZYL — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental application for Reblozyl (luspatercept) by Celgene Corporation. The action concerns updating the product's label…

• FDA approval · 2022-09-23
  FDA Approved: DEFERASIROX — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's Deferasirox as an original generic application, enabling broader access to this iron chelation therapy for patients with…

• EMA approval · 2022-07-14
  EMA Authorised: Deferiprone Lipomed (Deferiprone) — Lipomed GmbH

  EMA authorised Deferiprone Lipomed for iron overload and beta-thalassemia with Lipomed GmbH as marketing authorisation holder.

• FDA approval · 2021-04-30
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for Ferriprox (deferiprone) submitted by Chiesi USA, Inc. This action approves changes to the produc…

• FDA approval · 2020-04-03
  FDA Approved: REBLOZYL — Original Application (Celgene Corporation)

  FDA approved Reblozyl (luspatercept) in the original application for adults with transfusion-dependent anemia due to myelodysplastic syndrom…

• FDA approval · 2020-02-20
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for Ferriprox (deferiprone) submitted by Chiesi USA, Inc.

• FDA approval · 2019-11-20
  FDA Approved: DEFERASIROX — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the Original Application for Deferasirox from Alembic Pharmaceuticals Limited (ANDA211824).

• FDA approval · 2019-11-08
  FDA Approved: REBLOZYL — Original Application (Celgene Corporation)

  The FDA approved the original application for Reblozyl (luspatercept) from Celgene. This adds a new biologic for adults with transfusion-dep…

• FDA approval · 2011-08-10
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXJADE (deferasirox) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2010-01-28
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exjade (deferasirox) from Novartis Pharmaceuticals Corporation.