Irish biopharma company Elan has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to labels on its key Tysabri drug.
The application, which Elan made in conjunction with its partner Biogen Idec, is to allow for an expanded indication for the drug. That would allow for first-line use for people living with certain relapsing forms of multiple sclerosis who have tested negative for antibodies to the...
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