Acute Myeloid Leukemia
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-04EMA Authorised: Vyxeos liposomal (previously Vyxeos) (daunorubicin hydrochloride;cytarabine) — Jazz Pharmaceuticals Ireland Limited
Authorised status for Vyxeos liposomal (daunorubicin hydrochloride; cytarabine) for acute myeloid leukemia in Europe.
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FDA approval · 2026-04-13FDA Approved: VANFLYTA — Supplemental Application (Daiichi Sankyo Inc.)
FDA approved a supplemental application for VANFLYTA (quizartinib) submitted by Daiichi Sankyo Inc., resulting in changes to the drug's labe…
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FDA approval · 2026-04-09FDA Approved: ONUREG — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application for ONUREG (azacitidine) to support its use in maintenance therapy for adults with acute myeloid leu…
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EMA approval · 2026-02-25EMA Authorised: Tibsovo (Ivosidenib) — Les Laboratoires Servier
The European Medicines Agency authorised Tibsovo (ivosidenib) for acute myeloid leukemia and cholangiocarcinoma in the EU, with Les Laborato…
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FDA approval · 2026-02-06FDA Approved: IDAMYCIN PFS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for IDAMYCIN PFS (idarubicin hydrochloride) from Pfizer Laboratories Div Pfizer Inc.
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EMA approval · 2026-02-05EMA Authorised: Vanflyta (quizartinib dihydrochloride) — Daiichi Sankyo Europe GmbH
The European Medicines Agency authorised Vanflyta (quizartinib dihydrochloride) from Daiichi Sankyo Europe GmbH for the treatment of acute m…
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FDA approval · 2026-01-27FDA Approved: VYXEOS — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for VYXEOS (daunorubicin and cytarabine) liposome from Jazz Pharmaceuticals to support its use in ac…
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EMA approval · 2026-01-16EMA Authorised: Xospata (gilteritinib fumarate) — Astellas Pharma Europe B.V.
The EMA authorised Xospata (gilteritinib fumarate) for acute myeloid leukemia; the marketing authorization holder is Astellas Pharma Europe …
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EMA approval · 2026-01-14EMA Authorised: Rydapt (Midostaurin) — Novartis Europharm Ltd
The European Medicines Agency authorised Rydapt (midostaurin) for additional indications in acute myeloid leukemia and systemic mastocytosis…
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EMA approval · 2026-01-09EMA Authorised: Onureg (azacitidine) — Bristol-Myers Squibb Pharma EEIG
The European Medicines Agency authorised Onureg (azacitidine) for acute myeloid leukemia in adults in the European Union, with Bristol-Myers…
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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 · 2025-10-08EMA 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 · 2025-09-17EMA Authorised: Mylotarg (gemtuzumab ozogamicin) — Pfizer Europe MA EEIG
The EMA has authorized Mylotarg (gemtuzumab ozogamicin) for acute myeloid leukemia. The product carries orphan medicine designation.
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EMA approval · 2025-06-18EMA Authorised: Phelinun (melphalan hydrochloride) — ADIENNE S.r.l. S.U.
The EMA authorised Phelinun (melphalan hydrochloride) for multiple cancers including multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphom…
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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 · 2025-05-07EMA Authorised: Daurismo (Glasdegib maleate) — Pfizer Europe MA EEIG
The European Medicines Agency authorized Daurismo (glasdegib) from Pfizer Europe MA EEIG for acute myeloid leukemia, with orphan medicine de…
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FDA approval · 2025-01-16FDA Approved: IDHIFA — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application for IDHIFA (enasidenib mesylate) submitted by Celgene Corporation.
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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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FDA approval · 2024-12-19FDA Approved: CYCLOPHOSPHAMIDE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for cyclophosphamide, establishing a generic version of the chemotherapy agent.
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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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EMA approval · 2024-05-24EMA Authorised: Vyxeos liposomal (previously Vyxeos) (daunorubicin hydrochloride;cytarabine) — Jazz Pharmaceuticals Ireland Limited
The European Medicines Agency authorised Vyxeos liposomal (daunorubicin hydrochloride and cytarabine) for acute myeloid leukemia, with orpha…
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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.