Myelodysplastic Syndromes
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-12EMA Authorised: Azacitidine Mylan (azacitidine) — Mylan Pharmaceuticals Limited
European Medicines Agency authorises Azacitidine Mylan for myelodysplastic syndromes and various leukemias, confirming market authorization …
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EMA approval · 2026-03-12EMA Authorised: Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) (lenalidomide hydrochloride monohydrate) — Krka, d.d., Novo mesto
EMA authorised Lenalidomide Krka (lenalidomide hydrochloride monohydrate) for several hematologic malignancies, including multiple myeloma, …
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EMA approval · 2025-12-18EMA Authorised: Azacitidine Kabi (azacitidine) — Fresenius Kabi Deutschland GmbH
EMA authorised Azacitidine Kabi (azacitidine) from Fresenius Kabi Deutschland GmbH for use in the EU. The product is indicated for myelodysp…
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EMA approval · 2025-12-12EMA Authorised: Azacitidine Mylan (azacitidine) — Mylan Pharmaceuticals Limited
EU authorisation granted for Azacitidine Mylan for treatment of myelodysplastic syndromes and certain leukemias, expanding access to azaciti…
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EMA approval · 2025-12-09EMA Authorised: Dacogen (decitabine) — Janssen-Cilag International N.V.
The EMA authorised Dacogen (decitabine) for use in myeloid leukemias, including myelodysplastic syndromes and acute myeloid leukemia.
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EMA approval · 2025-11-24EMA 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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EMA approval · 2025-10-08EMA Authorised: Azacitidine Accord (azacitidine) — Accord Healthcare S.L.U.
EMA authorised Azacitidine Accord, a generic azacitidine product, for myelodysplastic syndromes and certain leukemias (acute myeloid leukemi…
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EMA approval · 2025-09-09EMA Authorised: Revlimid (lenalidomide) — Bristol-Myers Squibb Pharma EEIG
The European Medicines Agency authorised Revlimid (lenalidomide) for multiple indications including multiple myeloma, mantle cell lymphoma, …
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FDA approval · 2025-09-08FDA Approved: DEFERASIROX — Original Application (Aurobindo Pharma Limited)
The FDA approved an original ANDA for deferasirox (generic) manufactured by Aurobindo Pharma Limited, expanding access to iron chelation the…
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EMA approval · 2025-07-11EMA Authorised: Epoetin Alfa Hexal (epoetin alfa) — Hexal AG
The EMA authorised Epoetin Alfa Hexal (epoetin alfa) from Hexal AG to treat anemia associated with chronic kidney disease and related condit…
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EMA approval · 2025-07-11EMA Authorised: Binocrit (epoetin alfa) — Sandoz GmbH
EMA authorised Binocrit (epoetin alfa) by Sandoz GmbH for the treatment of anemia associated with chronic kidney disease, myelodysplastic sy…
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EMA approval · 2025-07-11EMA Authorised: Abseamed (epoetin alfa) — Medice Arzneimittel Pütter GmbH Co. KG
EMA has authorised Abseamed, an epoetin alfa product by Medice, for treatment of anemia associated with chronic kidney disease and certain h…
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FDA approval · 2025-05-20FDA Approved: AZACITIDINE — Original Application (Reliance Life Sciences Private Limited)
FDA approved the original application for azacitidine by Reliance Life Sciences Private Limited (ANDA217453), authorizing a generic version …
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EMA approval · 2025-05-15EMA Authorised: Rytelo (imetelstat) — Geron Netherlands B.V.
EMA authorised Rytelo (imetelstat) for the treatment of anemia in patients with myelodysplastic syndromes. The product has orphan medicine d…
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FDA approval · 2024-12-19FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for azacitidine submitted by BluePoint Laboratories.
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EMA approval · 2024-11-05EMA Authorised: Vidaza (azacitidine) — Bristol-Myers Squibb Pharma EEIG
The EMA authorised Vidaza (azacitidine) in the EU for myelodysplastic syndromes and certain leukemias, including chronic myelomonocytic leuk…
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FDA approval · 2024-10-15FDA Approved: AZACITIDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic azacitidine (AZACITIDINE) under an original application. The drug is indicated for myelodysplas…
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FDA approval · 2024-06-28FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for Vidaza (azacitidine) filed by Celgene Corporation.
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FDA approval · 2024-05-16FDA Approved: AZACITIDINE — Original Application (Sandoz Inc)
FDA approved Sandoz Inc.'s generic azacitidine (AZACITIDINE) as an Original Application under ANDA212580.
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FDA approval · 2024-03-29FDA Approved: AZACITIDINE — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for azacitidine from Accord Healthcare Inc., enabling continued regulatory authorization of the gene…
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EMA approval · 2024-01-10EMA Authorised: Azacitidine betapharm (azacitidine) — betapharm Arzneimittel GmbH
Azacitidine betapharm (azacitidine) has been authorised in the EU for use in myelodysplastic syndromes and various leukemias, with betapharm…
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FDA approval · 2023-06-28FDA Approved: AZACITIDINE — Original Application (Apotex Corp)
FDA approved Apotex Corp's generic azacitidine (AZACITIDINE) under an original ANDA; the product is indicated for treating certain myelodysp…
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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.
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FDA approval · 2023-03-06FDA Approved: LENALIDOMIDE — Original Application (EXELAN PHARMACEUTICALS INC.)
FDA approves a generic lenalidomide product from Exelan Pharmaceuticals under an original application. The drug is indicated for several hem…
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FDA approval · 2022-12-30FDA Approved: AZACITIDINE — Original Application (Eugia US LLC)
FDA approved the original application (ANDA) for azacitidine as a generic product, with Eugia US LLC listed as the manufacturer.