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April 28, 2021

Biogen Provides Regulatory Update on the Supplemental Biologic License Application (sBLA) for Subcutaneous Administration of TYSABRI® (natalizumab)

CAMBRIDGE, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its supplemental Biologic License Application (sBLA) for a new subcutaneous (SC) route of

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February 1, 2021

Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

Intramuscular injection PLEGRIDY (peginterferon beta-1a) is now approved in the U.S. and the European Union, offering individuals with relapsing multiple sclerosis (MS) a treatment option with significantly reduced injection site reactions PLEGRIDY has a well-characterized safety and efficacy

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January 29, 2021

Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is June 7, 2021 CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review

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January 13, 2021

Biogen to Report Fourth Quarter and Full Year 2020 Financial Results February 3, 2021

Cambridge, Mass. — Biogen Inc. (Nasdaq:BIIB) today announced it will report fourth quarter and full year 2020 financial results Wednesday, February 3, 2021, before the financial markets open.  Following the release of the financials, the Company will host a live webcast with Biogen management at

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January 11, 2021

Biogen to Launch Pioneering Study to Develop Digital Biomarkers of Cognitive Health Using Apple Watch and iPhone

The study aims to identify digital biomarkers to help monitor cognitive performance and health including potentially detecting mild cognitive impairment, an early indicator of certain forms of dementia such as Alzheimer’s disease  Cognitive health — the ability to think clearly, to learn and to

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January 8, 2021

Biogen to Participate in Webinar with Alzheimer's Disease International on January 14, 2021

Cambridge, Mass. – Biogen (Nasdaq: BIIB) today announced it will participate in a webinar with Alzheimer’s Disease International (ADI) including a presentation related to its Alzheimer’s disease investigational therapy, aducanumab, as well as a live question and answer (Q&A) session.

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January 8, 2021

Biogen Announces First Patient Treated in RESPOND Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated With Zolgensma® (onasemnogene abeparvovec)

The global Phase 4 RESPOND study will evaluate the efficacy and safety of SPINRAZA in patients with a suboptimal clinical response to Zolgensma Clinical and real-world experience have reported that some patients previously treated with Zolgensma have also been treated with SPINRAZA 1,2,3,4 Biogen

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January 4, 2021

Biogen to Present at the 39th Annual J.P. Morgan Healthcare Conference

Cambridge, MA, - - Biogen Inc .  (Nasdaq: BIIB) announced today that it will present at the virtual 39th Annual J.P. Morgan Healthcare Conference. The webcast will be live on Monday, January 11, 2021 at 10:00 a.m. ET. To access the live webcast, please visit Biogen’s Investors section at

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December 21, 2020

The European Commission Grants Marketing Authorization for PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Relapsing-Remitting Multiple Sclerosis

PLEGRIDY is now approved in the European Union for intramuscular injection, offering individuals with relapsing multiple sclerosis (MS) a differentiated, reliable treatment option combining safety and efficacy to help optimize their treatment experience with significantly reduced injection site

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December 9, 2020

Biogen Files New Drug Application for Aducanumab in Japan

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease Aducanumab is now under regulatory review in Japan, Europe and the United States CAMBRIDGE, Mass. and TOKYO, Dec. 09, 2020 (GLOBE NEWSWIRE) -- Today, Biogen (Nasdaq: BIIB) and Eisai,

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November 27, 2020

Biogen and Sage Therapeutics Announce Global Collaboration to Develop and Commercialize Potential Breakthrough Therapies in Depression and Movement Disorders

Biogen and Sage enter into an agreement to jointly develop and commercialize zuranolone and SAGE-324 in the U.S. Biogen to receive exclusive license to develop and commercialize zuranolone and SAGE-324 outside of the U.S . , excluding rights to zuranolone in Japan, Taiwan and South Korea Sage