Biogen Idec & Elan seek to update Tysabri labels in US and EU
This article was originally published in Scrip
Executive Summary
Biogen Idec and Elan have submitted an sBLA to the FDA and a Type II Variation to the EMA to request review and approval to update the label in each region for Tysabri (natalizumab) in order to provide details about JC virus antibody status.