Tysabri Risk Redux: Additional PML Cases Create REMS Challenge For FDA
Executive Summary
The emergence of two new cases of progressive multifocal leukoencephalopathy linked to Biogen Idec/Elan's Tysabri (natalizumab) comes just before the deadline for the firms to submit a formal Risk Evaluation and Mitigation Strategy for the product, and while FDA is still experimenting with how to apply its new REMS authorities
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