Sickle Cell Disease
📧 Sign up to get email alerts when something new happens for Sickle Cell Disease.
Sign up freeTop drugs studied for this disease
-
EMA approval · 2026-04-28EMA Authorised: Xromi (hydroxycarbamide) — Lipomed GmbH
Xromi (hydroxycarbamide) has been authorised in the EU for use in anemia and sickle cell disease.
-
EMA approval · 2026-04-28EMA Authorised: Siklos (hydroxycarbamide) — Theravia
Authorization of Siklos (hydroxycarbamide) in the European market for anemia and sickle cell indications.
-
EMA approval · 2026-02-19EMA 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 · 2026-02-11EMA Authorised: Siklos (hydroxycarbamide) — Theravia
EMA authorised Siklos (hydroxycarbamide) by Theravia for use in sickle cell disease.
-
EMA approval · 2025-11-03EMA Authorised: Xromi (hydroxycarbamide) — Lipomed GmbH
The EMA authorised Xromi, a hydroxycarbamide medicine from Lipomed GmbH, for indications in anemia and sickle cell disease.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2025-10-21FDA 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.
-
FDA approval · 2025-06-18FDA Approved: ENDARI — Supplemental Application (Emmaus Medical, Inc.)
FDA approved a supplemental application for ENDARI (glutamine) from Emmaus Medical, Inc., under a supplemental approval to update/expand the…
-
FDA approval · 2025-01-22FDA Tentative Approval: SIKLOS — Supplemental Application (Medunik)
FDA tentatively approved Medunik's supplemental application for Siklos (hydroxyurea), indicating approvable status for a hydroxyurea product…
-
FDA approval · 2024-09-23FDA Approved: HYDROXYUREA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Hydroxyurea, confirming an updated approval for the generic produ…
-
FDA approval · 2024-07-08FDA Approved: L-GLUTAMINE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original ANDA for L-Glutamine, authorizing a generic version of the drug.
-
FDA approval · 2024-06-26FDA Approved: ADAKVEO — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for ADAKVEO (crizanlizumab) submitted by Novartis Pharmaceuticals Corporation.
-
EMA approval · 2023-12-15First 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 · 2023-11-14FDA Approved: DEFERASIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for deferasirox submitted by Sun Pharmaceutical Industries, Inc., approving changes to the product l…
-
FDA approval · 2023-08-18FDA Approved: OXBRYTA — Supplemental Application (Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.)
FDA approved a supplemental application for OXBRYTA (voxelotor) submitted by Global Blood Therapeutics, Inc., a subsidiary of Pfizer, to upd…
-
FDA approval · 2023-08-18FDA Approved: OXBRYTA — Supplemental Application (Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.)
FDA approved a supplemental application for OXBRYTA (voxelotor) from Global Blood Therapeutics, a subsidiary of Pfizer Inc.
-
FDA approval · 2023-03-16FDA Approved: DEFERASIROX — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Deferasirox from Camber Pharmaceuticals, authorizing a generic product under ANDA 216229.
-
FDA approval · 2022-09-23FDA 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…
-
FDA approval · 2022-09-08FDA Approved: ADAKVEO — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for ADAKVEO (crizanlizumab) submitted by Novartis Pharmaceuticals Corporation, potentially expan…
-
FDA approval · 2021-12-17FDA Approved: OXBRYTA — Original Application (Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.)
FDA approves OXBRYTA (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients aged 12 months and older. This or…
-
EMA approval · 2021-12-17New treatment for sickle cell disease
The EMA announces a new treatment for sickle cell disease, indicating a regulatory approval or positive assessment expanding options for pat…
-
FDA approval · 2021-12-17FDA Approved: OXBRYTA — Supplemental Application (Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.)
FDA approved a supplemental application for OXBRYTA (voxelotor) submitted by Global Blood Therapeutics, a Pfizer subsidiary, related to sick…
-
FDA approval · 2021-07-12FDA Approved: ADAKVEO — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for ADAKVEO (crizanlizumab) submitted by Novartis Pharmaceuticals Corporation. The action involves r…
-
FDA approval · 2020-10-29FDA Approved: ENDARI — Supplemental Application (Emmaus Medical, Inc.)
FDA approved a supplemental application for Endari (L-glutamine) from Emmaus Medical, Inc.
-
FDA approval · 2020-06-15FDA Approved: DEFERASIROX — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal's generic deferasirox (Deferasirox) as an original ANDA for the treatment of transfusion-related iron overload in pa…
-
FDA approval · 2020-04-22FDA Approved: ENDARI — Supplemental Application (Emmaus Medical, Inc.)
FDA approved a supplemental application for ENDARI (L-glutamine) from Emmaus Medical, Inc., updating its regulatory status.