Pharmacy
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MM drug disappoints in phase 3 trial
Single-agent carfilzomib did not improve overall survival compared to an active control regimen of corticosteroids plus optional cyclophosphamide...
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Drug on the fast track to treat AML
Credit: Esther Dyson The US Food and Drug Administration (FDA) has granted fast track designation for AG-221 to treat acute myelogenous leukemia...
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ESA recalled due to particulates
Amgen is recalling lots of the erythropoiesis-stimulating agent Aranesp (darbepoetin alfa) that were distributed in several countries outside the...
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HDAC inhibitor gets orphan status for DLBCL
The US Food and Drug Administration (FDA) has granted orphan designation for the histone deacetylase (HDAC) inhibitor mocetinostat to treat...
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Antibiotic recalled due to presence of particulates
Cubist Pharmaceuticals, Inc.
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FDA approves bortezomib retreatment in MM
Bortezomib’s label has been updated to include dosing guidelines and safety and efficacy findings for single-agent bortezomib and bortezomib in...
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Drug gets fast track designation for MF
Credit: Peter Anderson The US Food and Drug Administration (FDA) is expediting its review of pacritinib, a tyrosine kinase inhibitor with...
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Ofatumumab prompts fatal reaction in CLL patient
Credit: Bill Branson Health Canada and GlaxoSmithKline (GSK) have reported a fatal infusion reaction in a patient receiving the monoclonal...
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CHMP recommends antifungal agent
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for intravenous (IV) posaconazole (...
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Expediting drug approvals may compromise safety
Credit: CDC The introduction of expedited drug approvals in the US coincides with an increase in black box warnings and market withdrawals, a new...
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FDA aims for tighter regulation of diagnostic tests
Credit: William Weinert The US Food and Drug Administration (FDA) is taking steps to ensure better regulation of certain diagnostic tests. The...