Acute Myeloid Leukemia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS approval · 2018-07-24Clinical Trial Update: Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
This clinical trial update describes an expanded access program for Ivosidenib in relapsed/refractory IDH1-mutant acute myeloid leukemia. It…
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FDA approval · 2018-07-20FDA Approved: TIBSOVO — Original Application (Servier Pharmaceutical LLC)
FDA approved Tibsovo (ivosidenib) in its original application for the treatment of acute myeloid leukemia, supporting use in patients with I…
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FDA approval · 2018-07-17FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approves the original application for CYTARABINE (cytarabine) from Meitheal Pharmaceuticals Inc., making a generic cytarabine product av…
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FDA approval · 2018-07-02FDA Approved: AZACITIDINE — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original application for azacitidine, providing a generic version of the cancer drug indicated for mye…
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FDA approval · 2018-04-09FDA Approved: MYLOTARG — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for MYLOTARG (gemtuzumab ozogamicin) submitted by Wyeth Pharmaceuticals LLC (a subsidiary of Pfi…
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CLINICAL_TRIALS approval · 2018-03-02Clinical Trial Update: Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia
Gemtuzumab ozogamicin has been approved for marketing for relapsed or refractory acute myeloid leukemia and acute promyelocytic leukemia bas…
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FDA approval · 2018-01-10FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for azacitidine submitted by BluePoint Laboratories. This indicates regulatory approval of modif…
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FDA approval · 2017-11-09FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved the original abbreviated new drug application for Cytarabine from Meitheal Pharmaceuticals, enabling the generic injectable…
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FDA approval · 2017-11-03FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for doxorubicin hydrochloride from BluePoint Laboratories, adding a new approved generic version of …
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FDA approval · 2017-09-22FDA Approved: DECITABINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's original ANDA for decitabine, a generic chemotherapy agent. It is indicated for the treatment of myelodysplastic syndr…
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FDA approval · 2017-09-01FDA Approved: MYLOTARG — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approval of Mylotarg (gemtuzumab ozogamicin) under the original application from Wyeth/Pfizer for treatment of acute myeloid leukemia.
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CLINICAL_TRIALS approval · 2017-08-22Clinical Trial Update: EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML
CPX-351 (Vyxeos) has received marketing approval for adults aged 60-75 with secondary acute myeloid leukemia.
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FDA approval · 2017-08-01FDA Approved: IDHIFA — Original Application (Celgene Corporation)
FDA approves IDHIFA (enasidenib) in the original application for adult patients with relapsed or refractory acute myeloid leukemia harboring…
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FDA approval · 2017-07-28FDA Approved: AZACITIDINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved Dr. Reddy's Laboratories Inc.'s supplemental application for azacitidine. The action pertains to a supplemental filing for the …
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FDA approval · 2017-04-28FDA Approved: RYDAPT — Original Application (Novartis Pharmaceuticals Corporation)
FDA approved RYDAPT (midostaurin) under its original application for an indication in adults with acute myeloid leukemia with FLT3 mutation,…
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FDA approval · 2017-02-27FDA Approved: DECITABINE — Original Application (Accord Healthcare Inc.)
FDA approves an original ANDA for decitabine by Accord Healthcare Inc., establishing a generic version of the drug.
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FDA approval · 2017-01-30FDA 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 · 2016-09-29FDA Approved: AZACITIDINE — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's azacitidine injection as an original application (ANDA) for a generic version. It is approved for the…
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FDA approval · 2016-08-23FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation, updating/adding to the product's labe…
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FDA approval · 2016-03-16FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Decitabine filed by Sun Pharmaceutical Industries, Inc. The approval updates the product's label…
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FDA approval · 2015-06-01FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for mitoxantrone hydrochloride, submitted by Fresenius Kabi USA, LLC.
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FDA approval · 2015-02-23FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation.
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FDA approval · 2014-12-04FDA 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. The action repr…
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FDA approval · 2014-11-05FDA Approved: DOXORUBICIN HYDROCHLORIDE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for doxorubicin hydrochloride (Fresenius Kabi USA, LLC) under anANDA to support its generic product.
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FDA approval · 2014-10-25FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)
FDA approved a supplemental application for Civica, Inc. to market a generic cyclophosphamide product.