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February 01, 2021 07:30 ET | Source: Biogen Inc.

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...
January 29, 2021 07:30 ET | Source: Biogen Inc.

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....
January 11, 2021 07:30 ET | Source: Biogen Inc.

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...
January 08, 2021 07:30 ET | Source: Biogen Inc.

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 ZolgensmaClinical and real-world experience have reported that...
December 21, 2020 07:30 ET | Source: Biogen Inc.

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...
December 09, 2020 22:30 ET | Source: Biogen Inc.

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 diseaseAducanumab is now under regulatory review in Japan, Europe and the United States ...
November 27, 2020 07:30 ET | Source: Biogen Inc.; Sage Therapeutics

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...
November 18, 2020 07:00 ET | Source: Biogen Inc.

Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)

INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA)...
November 16, 2020 07:30 ET | Source: Biogen Inc.

Biogen Ranked #1 Biotechnology Company by Dow Jones Sustainability World Index for an Industry Record 5th Time; Recognition Reflects Longstanding ESG Leadership

Biogen earns top scores on areas including access to medicine, talent attraction, innovation management and climate performance and reportingIn 2013 Biogen became the 1st U.S. biotech company to...
November 06, 2020 20:15 ET | Source: Biogen Inc.

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

CAMBRIDGE, Mass. and TOKYO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Today, the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted 1 yes, 8 no and...