Leukemia

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Clinical Implications Remain After Dasatinib CRL in CML/ALL
Clinical Implications Remain After Dasatinib CRL in CML/ALL

October 28th 2025

The FDA's CRL for the HyNap formulation of dasatinib due to manufacturing issues does not affect the efficacy or availability of standard dasatinib.

What Path to Approval Has Dasatinib Taken in CML/ALL?
What Path to Approval Has Dasatinib Taken in CML/ALL?

October 27th 2025

Results from the phase 1/2 AUGMENT-101 trial support the FDA’s decision for approving revumenib in this NPM1-mutated, relapsed/refractory AML population.
FDA Approves Revumenib in R/R NPM1-Mutant AML

October 24th 2025

The FDA has set a Prescription Drug User Fee Act date of June 18, 2026, for approving this formulation of nilotinib in chronic myeloid leukemia.
FDA Accepts NDA for New Nilotinib Formulation in CML

October 23rd 2025

FDA Issues CRL for Dasatinib in CML/ALL
FDA Issues CRL for Dasatinib in CML/ALL

October 20th 2025

Video Series
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Jorge Cortes, MD, outlines the impact of imatinib in chronic myeloid leukemia and highlights future initiatives in the field.
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