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News FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). |
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News European Commission Approves Inclusion of Anti-JC Virus Antibody Status as a PML Risk Factor in TYSABRI Labeling
Biogen Idec and Elan Corporation, plc announced that the European Commission (EC) has approved the inclusion of anti-JC virus (JCV) antibody status as an additional factor to aid in stratifying patients at risk for developing progressive multifocal leukoencephalopathy (PML) in the Summary of Product Characteristics (SmPC) for TYSABRI® (natalizumab) in the European Union (EU). |