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FDA issues complete response letter for Tysabri supplemental filing in SC form for multiple sclerosis – Biogen

Written by | 7 May 2021

Biogen Inc. announced that it has received a Complete Response Letter from the FDA for its supplemental Biologic License Application (sBLA) for a new subcutaneous route of administration… read more.

EU approves SC version of Tysabri for multiple sclerosis – Biogen

Written by | 14 Apr 2021

Biogen announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).

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