Myelomonocytic Leukemia
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Sign up freeTop drugs studied for this disease
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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 · 2025-10-08EMA 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 · 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 · 2024-05-16FDA 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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FDA approval · 2022-09-23FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation.
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FDA approval · 2022-03-24FDA Approved: INQOVI — Supplemental Application (Taiho Pharmaceutical Co., Ltd.)
The FDA approved a supplemental application for INQOVI, the oral fixed-dose combination of cedazuridine and decitabine from Taiho Pharmaceut…
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FDA approval · 2020-07-13FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for azacitidine submitted by BluePoint Laboratories, representing a modification to the existing NDA…
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FDA approval · 2020-07-07FDA Approved: INQOVI — Original Application (Taiho Pharmaceutical Co., Ltd.)
FDA approved INQOVI (cedazuridine and decitabine) from Taiho Pharmaceutical Co., Ltd. under an original NDA (NDA 212576) for adults with mye…
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FDA approval · 2020-06-08FDA Approved: AZACITIDINE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic azacitidine (AZACITIDINE) through an Original Application (ANDA 209337). This adds a g…
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FDA approval · 2013-05-06FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)
The FDA approved a Celgene-supplied supplemental application for Vidaza (azacitidine), updating the drug's labeling and/or indications.