Biogen and Elan seek additional labeling for MS drug Tysabri to test for PML
USA-based Biogen Idec (Nasdaq: BIIB) and Irish marketing partner Elan (NYSE: ELN) have submitted a supplemental Biologics License Application to the US Food and Drug Administration and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective Prescribing Information and Summary of Product Characteristics for their multiple sclerosis drug Tysabri (natalizumab).
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