Chronic Myeloid Leukemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-08-28FDA Approved: DASATINIB — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for dasatinib (generic), enabling the continued availability of a generic DASATINIB thr…
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FDA approval · 2025-08-27FDA Approved: DASATINIB — Original Application (Teva Pharmaceuticals, Inc.)
The FDA approved Teva Pharmaceuticals' original application to market a generic dasatinib product.
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FDA approval · 2025-08-01FDA Approved: PHYRAGO — Supplemental Application (Cycle Pharmaceuticals Ltd)
The FDA has approved a supplemental application for PHYRAGO (dasatinib) from Cycle Pharmaceuticals Ltd.
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FDA approval · 2025-07-10FDA Approved: NILOTINIB — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for nilotinib from Cipla USA Inc., indicating an approved update to the drug's labeling or indic…
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FDA approval · 2025-04-22FDA Approved: DASATINIB — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for dasatinib from Aurobindo Pharma Limited (generic dasatinib).
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FDA approval · 2025-04-14FDA Approved: IMATINIB MESYLATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' imatinib mesylate as an original (ANDA) generic product.
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FDA approval · 2025-03-20FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for imatinib mesylate (Teva) under an ANDA, authorizing continued regulatory approval for this gener…
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FDA approval · 2025-03-03FDA Approved: DASATINIB — Original Application (Biocon Pharma Inc.)
FDA approves Biocon Pharma Inc.'s original application for dasatinib (generic) to treat certain leukemias, marking the availability of a gen…
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FDA approval · 2025-03-03FDA Approved: DASATINIB — Original Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved an original application for dasatinib from Zydus Pharmaceuticals USA Inc., enabling a generic version of the cancer drug. D…
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FDA approval · 2025-03-03FDA Approved: DASATINIB — Original Application (Dr.Reddys Laboratories Inc)
FDA approved the original application for dasatinib by Dr. Reddy's Laboratories Inc, providing a generic version of dasatinib for leukemias.…
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FDA approval · 2025-02-19FDA Approved: NILOTINIB — Original Application (Cipla USA Inc.)
FDA approval of an Original Application for nilotinib by Cipla USA Inc., a generic version of Tasigna for treatment of Philadelphia chromoso…
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FDA approval · 2025-01-08FDA Approved: IMATINIB MESYLATE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental ANDA for Imatinib Mesylate (Chartwell RX, LLC), enabling marketing of a generic version of the cancer drug.
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FDA approval · 2024-12-09FDA Approved: IMATINIB MESYLATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for imatinib mesylate from Mylan Pharmaceuticals, effectively authorizing a supplemental approva…
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FDA approval · 2024-12-03FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Bosulif (bosutinib) from Pfizer Laboratories Div Pfizer Inc, updating the drug's labeling.
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FDA approval · 2024-12-03FDA Approved: PHYRAGO — Supplemental Application (Cycle Pharmaceuticals Ltd)
FDA approved a supplemental application for PHYRAGO (dasatinib) submitted by Cycle Pharmaceuticals Ltd.
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FDA approval · 2024-11-22FDA Approved: IMKELDI — Original Application (Shorla Oncology Inc.,)
FDA approved IMKELDI (imatinib oral) under an original NDA from Shorla Oncology, authorizing a new imatinib product for several cancers incl…
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FDA approval · 2024-11-07FDA Approved: DANZITEN — Original Application (Azurity Pharmaceuticals, Inc.)
FDA approved the Original Application for DANZITEN (nilotinib) from Azurity Pharmaceuticals, establishing a branded nilotinib product for Ph…
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FDA approval · 2024-10-29FDA Approved: SCEMBLIX — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Scemblix (asciminib) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2024-08-07FDA Approved: SCEMBLIX — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for SCEMBLIX (asciminib) from Novartis, expanding its label for chronic myeloid leukemia in patients…
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FDA approval · 2024-07-31FDA Approved: DASATINIB — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for dasatinib submitted by Prasco Laboratories, resulting in an approved change to its labeling and/…
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FDA approval · 2024-07-31FDA Approved: PHYRAGO — Supplemental Application (Cycle Pharmaceuticals Ltd)
The FDA approved a supplemental application for PHYRAGO (dasatinib) from Cycle Pharmaceuticals Ltd, indicating an update to the product's la…
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FDA approval · 2024-06-18FDA Approved: SCEMBLIX — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for SCEMBLIX (asciminib) from Novartis Pharmaceuticals Corporation. The approval updates the drug's …
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FDA approval · 2024-03-19FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) submitted by Takeda Pharmaceuticals America, Inc. The appr…
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FDA approval · 2024-03-01FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis Pharmaceuticals Corporation. This action confi…
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FDA approval · 2024-02-06FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TASIGNA (nilotinib) submitted by Novartis, resulting in changes to the labeling under the supple…