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Identifying patients with a high risk of AML
Researchers say they have found ways to identify patients with a high risk of developing acute myeloid leukemia (AML). The researchers used basic...
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FDA grants EUA for freeze-dried plasma product
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a freeze-dried plasma product to be used by the...
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New approach to AE reporting needed, group says
A group of experts has called for improvements in reporting adverse events (AEs) that occur in patients with hematologic malignancies. The group...
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Health Canada expands approval of obinutuzumab
Health Canada has expanded the approved use of obinutuzumab (Gazyva®). The anti-CD20 monoclonal antibody is now approved for use in combination...
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A new use for ibrutinib?
Preclinical research suggests ibrutinib could treat G-CSFR-mutant myeloid disorders. “Mutations in G-CSFR have a harmful effect on the production...
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Conflicts of interest among FDA advisers
An investigative report has unearthed potential conflicts of interest among physicians who serve on advisory panels for the US Food and Drug...
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ESMO, ASCO seek improved cancer services
The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have called for renewed political commitment...
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FDA revises guidance on screening blood for Zika
The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus. The...
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EC approves new use, formulation of dasatinib
The European Commission (EC) has expanded the marketing authorization for dasatinib (Sprycel). The drug is now approved to treat patients ages 1...
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Drug proves active in resistant MM
STOCKHOLM—The alkylating peptide melflufen has demonstrated activity in patients with treatment-resistant multiple myeloma (MM). In a phase 2...
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Lower risk of bleeding with apixaban
Real-world data suggest that apixaban poses a lower risk of bleeding than warfarin, but patients who receive lower doses of apixaban have an...
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JAK inhibition linked to B-cell lymphoma
New research indicates that JAK inhibitors may increase the risk of lymphoma in patients with myelofibrosis (MF). The patients studied had a 15-...
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Cell therapy receives RMAT designation
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for romyelocel-L, a myeloid...
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CHMP recommends rVWF for VWD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for vonicog alfa (...
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CHMP supports authorization of drug for AML
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for CPX-351 (Vyxeos...