Chronic Myeloid Leukemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-08-17FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for imatinib mesylate, a generic version of the cancer drug, to update its approval status.
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FDA approval · 2016-08-04FDA Approved: IMATINIB MESYLATE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approval of Teva's Imatinib Mesylate Original Application under ANDA204285 for a generic Imatinib product.
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FDA approval · 2016-06-10FDA Approved: DASATINIB — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original generic application for dasatinib (DASATINIB). The approval provides a generic version of dasatinib for…
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FDA approval · 2016-03-23FDA Approved: DROXIA — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for DROXIA (hydroxyurea) filed by Waylis Therapeutics LLC.
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FDA approval · 2015-12-03FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)
FDA approved the original application for Imatinib Mesylate from BluePoint Laboratories (ANDA078340), authorizing a generic version of the c…
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FDA approval · 2015-12-01FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) submitted by Takeda Pharmaceuticals America, Inc., under NDA 2…
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FDA approval · 2015-10-15FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. The approval pertains to …
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FDA approval · 2015-10-08FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Bosulif (bosutinib) submitted by Pfizer Laboratories Div Pfizer Inc. This approval updates a…
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FDA approval · 2015-09-22FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for BOSULIF (bosutinib) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2015-04-23FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) submitted by Takeda Pharmaceuticals America, Inc., under NDA 2…
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FDA approval · 2014-11-25FDA Approved: BOSULIF — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental NDA for Bosulif (bosutinib) from Pfizer Laboratories Div Pfizer Inc, resulting in an approved change to the prod…
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FDA approval · 2014-09-25FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2014-09-04FDA Approved: BUSULFEX — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for BUSULFEX (busulfan) submitted by Otsuka America Pharmaceutical, Inc.
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FDA approval · 2014-07-30FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA granted approval of a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-07-24FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-01-30FDA Approved: ICLUSIG — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ICLUSIG (ponatinib hydrochloride) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2013-08-14FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) from Novartis Pharmaceuticals Corporation. The approval updates the labeling…
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FDA approval · 2013-05-22FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) to update the product labeling.
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FDA approval · 2013-05-17FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TASIGNA (nilotinib) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2013-01-25FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis, reflecting changes to the product labeling.
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FDA approval · 2012-12-20FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) submitted by Novartis Pharmaceuticals Corporation. The action typically upda…
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FDA approval · 2012-12-14FDA Approved: ICLUSIG — Original Application (Takeda Pharmaceuticals America, Inc.)
This FDA page documents the original approval of ICLUSIG (ponatinib hydrochloride) by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2012-09-04FDA Approved: BOSULIF — Original Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved BOSULIF (bosutinib) from Pfizer for adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) with resistance…
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CLINICAL_TRIALS approval · 2012-07-18Clinical Trial Update: Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Marketing approval of nilotinib for adult chronic myeloid leukemia in imatinib-resistant or intolerant patients across blast crisis, acceler…
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FDA approval · 2011-01-14FDA Approved: TASIGNA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tasigna (nilotinib) by Novartis Pharmaceuticals to modify labeling and/or expand its approved in…