Pharmacy
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FDA: Long-term clopidogrel doesn’t affect risk of death
A review conducted by the US Food and Drug Administration (FDA) indicates that long-term use of the antiplatelet drug clopidogrel (Plavix) does...
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FDA grants drug priority review as FL therapy
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application for obinutuzumab (Gazyva)...
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EC expands indication for azacitidine in AML
The European Commission (EC) has expanded the approved indication for azacitidine for injection (Vidaza) in acute myeloid leukemia (AML). Now,...
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Drug gets orphan designation for BPDCN
The European Medicines Agency (EMA) has granted orphan drug designation to SL-401 for the treatment of blastic plasmacytoid dendritic cell...
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Iron chelator tablets may now be crushed
Photo courtesy of the CDC The US Food and Drug Administration (FDA) has approved a label change for Jadenu, an oral formulation of the iron...
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WHO recommends pilot projects for malaria vaccine
a malaria-endemic region Photo by Sarah Mattison More testing is needed before the malaria vaccine candidate RTS,S/AS01 (Mosquirix) can be put...
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New melphalan formulation denied approval
Photo by Chad McNeeley The US Food and Drug Administration (FDA) has said that, at present, it cannot approve a propylene glycol-free melphalan...
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FDA approves factor X concentrate
The US Food and Drug Administration (FDA) has approved a factor X product derived from human plasma (Coagadex) to treat patients with hereditary...
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Drug granted breakthrough designation for ALL
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for inotuzumab ozogamicin to treat adults with acute...
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FDA approves reversal agent for dabigatran
treating a patient Photo by Tom Watanabe The US Food and Drug Administration (FDA) has granted accelerated approval for idarucizumab (Praxbind),...
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Watchdog condemns FDA oversight of dabigatran
Photo by ec-jpr The US Food and Drug Administration’s (FDA’s) oversight of the oral anticoagulant dabigatran (Pradaxa) raises questions about the...