Acute Myeloid Leukemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-09-22FDA Approved: AZACITIDINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Dr. Reddy's azacitidine (AZACITIDINE).
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FDA approval · 2020-09-16FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Decitabine submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2020-08-06FDA Approved: AZACITIDINE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for azacitidine submitted by Fresenius Kabi USA, LLC.
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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 · 2020-06-26FDA Approved: CYTARABINE — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approval of Meitheal Pharmaceuticals' original ANDA for Cytarabine (cytarabine), a generic injectable anticancer agent.
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FDA approval · 2020-06-16FDA 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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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 · 2020-03-19FDA Approved: DAURISMO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for DAURISMO (glasdegib) filed by Pfizer Laboratories Div Pfizer Inc, resulting in an updated la…
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FDA approval · 2020-03-18FDA Approved: VIDAZA — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application for Vidaza (azacitidine) submitted by Celgene Corporation.
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FDA approval · 2020-02-27FDA 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 (Pfizer), updating its l…
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FDA approval · 2020-02-03FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for decitabine submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2020-01-13FDA Approved: VYXEOS — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approves a supplemental application for VYXEOS (daunorubicin and cytarabine liposome) from Jazz Pharmaceuticals, expanding its approved …
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FDA approval · 2019-10-09FDA Approved: DECITABINE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Decitabine from Dr. Reddy's Laboratories Inc., expanding regulatory approval for this generic hy…
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FDA approval · 2019-09-27FDA Approved: IDHIFA — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for IDHIFA (enasidenib mesylate) from Celgene, updating the labeling and/or expanding its indica…
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FDA approval · 2019-07-22FDA Approved: AZACITIDINE — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for azacitidine.
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FDA approval · 2019-05-29FDA Approved: XOSPATA — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for XOSPATA (gilteritinib) submitted by Astellas Pharma US, Inc., resulting in changes to the pr…
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FDA approval · 2019-05-22FDA Approved: DECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for DECITABINE, submitted by Sun Pharmaceutical Industries, Inc. This action updates the regulatory …
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FDA approval · 2019-05-02FDA Approved: TIBSOVO — Supplemental Application (Servier Pharmaceutical LLC)
The FDA approved a supplemental application for TIBSOVO (ivosidenib) submitted by Servier Pharmaceutical LLC.
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FDA approval · 2019-04-18FDA Approved: BUSULFAN — Original Application (Armas Pharmaceuticals Inc.)
FDA approved a generic Busulfan from Armas Pharmaceuticals Inc. under ANDA210931, enabling a generic formulation.
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FDA approval · 2019-01-18FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of a generic formulation …
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FDA approval · 2018-11-28FDA Approved: XOSPATA — Original Application (Astellas Pharma US, Inc.)
FDA approved XOSPATA (gilteritinib) as an original application for adult patients with relapsed or refractory FLT3-mutated acute myeloid leu…
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FDA approval · 2018-11-21FDA Approved: DAURISMO — Original Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved DAURISMO (glasdegib) from Pfizer as an original NDA for the treatment of adults with acute myeloid leukemia who are not candida…
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FDA approval · 2018-10-22FDA Approved: AZACITIDINE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for azacitidine from BluePoint Laboratories, indicating an update to the drug's labeling or indicati…
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FDA approval · 2018-09-28FDA Approved: BUSULFEX — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for Busultex (busulfan) filed by Otsuka America Pharmaceutical, Inc. The action updates the labeling…
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FDA approval · 2018-09-27FDA Approved: DAUNORUBICIN HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for daunorubicin hydrochloride (Hikma Pharmaceuticals USA Inc.).