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Update on the phase IV confirmatory study of Aduhelm for Alzheimer’s disease – Biogen + Eisai

Written by | 31 Jan 2022

Biogen Inc. and Eisai Co., Ltd. provided an important update on the continuing progress of the Phase IV post-marketing confirmatory study of Aduhelm (aducanumab-avwa) 100 mg/mL injection for… read more.

FDA grants accelerated approval for Aduhelm to treat Alzheimer’s disease – Biogen + Eisai

Written by | 15 Jun 2021

Biogen and Eisai, Co., Ltd. announced that the FDA has granted accelerated approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’sdisease treatment to address a defining pathology… read more.

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).

FDA approves intramuscular injection route of administration of Plegridy for multiple sclerosis – Biogen

Written by | 9 Feb 2021

Biogen Inc. announced that the FDA has approved a new intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple… read more.

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