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Biogen Inc. news

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Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Designated for Priority Review in China

February 8, 2026

Sales of Leqembi® totaled 20.7 billion yen in the fourth quarter 2025

February 6, 2026

Nature Medicine Publishes Results from the Pivotal DEVOTE Study of High-Dose Regimen of Nusinersen in Spinal Muscular Atrophy

February 4, 2026

Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus

January 28, 2026

Biogen’s Litifilimab Receives FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus, a Disease With No Targeted Treatment Options

January 28, 2026

FDA Accepts LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease under Priority Review

January 25, 2026

FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review

January 24, 2026

Biogen Receives European Commission Approval for High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

January 12, 2026

Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Accepted in China

January 5, 2026

Samsung Bioepis Begins Commercialization of BYOOVIZ®, Biosimilar to Lucentis (Ranibizumab), in Europe

January 2, 2026

The Journal of the American Medical Association (JAMA) Neurology Publishes Long Term Results from the QALSODY Phase 3 VALOR Study and its Open-Label Extension in SOD1-ALS

December 22, 2025

Great Point Partners Acquires a Majority Stake in Lenis Group, a Full-Service Specialty Pharmaceutical Commercialization and Distribution Partner

December 10, 2025

Biogen Receives Health Canada Authorization for ZURZUVAE™ (zuranolone), the First and Only Treatment Indicated for Adults with Postpartum Depression in Canada

December 9, 2025

“LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Included in China’s Commercial Insurance Innovative Drug List

December 8, 2025

Biogen and Stoke Therapeutics Present Data that Further Support the Disease-Modifying Potential of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome, at the 2025 American Epilepsy Society (AES) Annual Meeting

December 5, 2025

Eisai Presents New Data on the Continued and Expanding Benefit of LEQEMBI® (lecanemab-irmb) Maintenance Treatment in Early Alzheimer's Disease at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2025

December 3, 2025

New Data Presented at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2025 Confirms Pharmacological Effect of LEQEMBI® (lecanemab-irmb) on Neurotoxic Aβ Protofibrils in CSF

December 2, 2025

Biogen and Stoke Therapeutics Announce Presentations at the 2025 American Epilepsy Society Annual Meeting

December 1, 2025

Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan

November 27, 2025

Eisai Completes Rolling Submission to US FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status

November 25, 2025

Biogen and Dayra Therapeutics Announce Research Collaboration to Discover and Develop Oral Macrocyclic Peptides for a Range of Immunological Conditions

November 23, 2025

Biogen to Highlight New Lecanemab Data and Scientific Advances at the 18th Clinical Trials on Alzheimer’s Disease Conference

November 20, 2025

Biogen and Stoke Therapeutics Announce Publication of Two-Year Natural History Data Demonstrating the Severity of Dravet Syndrome, Including Frequent Seizures and Significant Cognitive and Behavioral Impairments

November 16, 2025

Biogen Completes Acquisition of Alcyone Therapeutics

November 13, 2025

“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom

November 13, 2025

Antibody-Mediated Rejection Market Set to Expand Significantly During the Forecast Period (2025-2034) Amid Advances in Diagnostics and Targeted Therapies | DelveInsight

November 11, 2025

Biogen to Highlight Scientific Progress in Rare Kidney Disease at American Society of Nephrology (ASN) Kidney Week 2025

November 3, 2025

Sales of Leqembi® totaled 18 billion yen in the third quarter 2025

October 30, 2025

Health Canada Grants Authorization for “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease

October 26, 2025

Biogen Licenses Oral C5aR1 Antagonist from Vanqua Bio to Expand Immunology Portfolio

October 23, 2025

Biogen to Present Additional Results from Phase 3 Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus at ACR Convergence 2025

October 22, 2025

IMPALA Appoints Ann Marie Dunne as New Chair, Succeeding Jonathan Taylor

October 20, 2025

Newleos Therapeutics CEO David Donabedian Recognized by Goldman Sachs as One of the Most Exceptional Entrepreneurs at the 2025 Builders and Innovators Summit

October 15, 2025

LEQEMBI® IQLIK™(lecanemab-irmb) Subcutaneous Autoinjector Named to TIME’s “Best Inventions of 2025”

October 13, 2025

Global Leaders Jesús Mantas and Wes Bricker Join NACD Board of Directors

October 10, 2025

Biogen and Stoke Therapeutics Present New Data at the 54th Child Neurology Society (CNS) Annual Meeting that Support the Potential of Zorevunersen as a Disease-Modifying Medicine for Dravet Syndrome

October 9, 2025

Neuromuscular Disease Therapeutics Market to Reach US$ 45.62 Billion by 2033 as Gene Therapies and RNA-based Treatments Redefine Patient Outcomes

October 7, 2025

Rare Disease Therapeutics Market to Surpass US$ 495.27 Billion by 2033 as Gene Therapy, RNA-based Drugs, and Biologics Transform Patient Care

October 7, 2025

Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer’s Disease

October 5, 2025

“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China

September 28, 2025

LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Australia

September 24, 2025

Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen

September 22, 2025

Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates

September 17, 2025

Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe

September 16, 2025

Biogen and Stoke Therapeutics Present Data at the 36th International Epilepsy Congress that Support the Potential for Zorevunersen to be the First Disease-Modifying Medicine for Dravet Syndrome

September 2, 2025

FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease

August 28, 2025

Biogen and Stoke Therapeutics Announce Presentations of Clinical Data from Studies of Zorevunersen for the Potential Treatment of Dravet Syndrome at the 36th International Epilepsy Congress

August 25, 2025

eGenesis Appoints Douglas Williams, Ph.D., and Adam Craig, M.D., Ph.D., to its Board of Directors

August 19, 2025

New.med Domain Names Surpass 40,000 Pre-Orders in July

August 12, 2025

Biogen and Stoke Therapeutics Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome

August 10, 2025

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