In November 2025, Biogen received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of a high dose nusinersen regimen for 5q ...
Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen of nusinersen in treatment-naive participants and those transitioning from the currently approved 12m ...
Biogen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has ...
SMA is a rare, genetic neuromuscular condition that affects people across age groups. With treatment landscapes evolving ...
Positive study demonstrates the potential for investigational higher dose nusinersen regimen to advance the treatment of SMA; Biogen plans to submit for regulatory approval of this investigational ...
New analyses from DEVOTE Part C further characterize the improvements in motor function in participants with SMA who transitioned to the investigational higher dose regimen of nusinersen from 12 mg ...
Biogen (BIIB) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a ...
CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company ...
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, and the European Medicines Agency, EMA, has validated the ...
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