Nasdaq

Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy

Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular atrophy ...

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

Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and ...
Nasdaq

Biogen Inc. Reports Positive Findings from DEVOTE and NURTURE Studies on Higher Dose Regimen of Nusinersen for Spinal Muscular Atrophy

New data from Biogen shows improved motor function in SMA patients using a higher dose of nusinersen, highlighting early treatment benefits. Biogen announced new data from the DEVOTE Part C and ...
Seeking Alpha

Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen

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 ...
Business Insider

Biogen announces FDA, EMA accepted applications for higher dose of nusinersen

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 ...
Seeking Alpha

High Dose Regimen of Nusinersen Receives Positive CHMP Opinion for the Treatment of Spinal Muscular Atrophy

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 ...
The Pharma Letter

Europe clears Biogen’s high-dose Spinraza regimen

US biotech Biogen (Nasdaq: BIIB) said the European Commission on January 12, 2026 granted marketing authorization for a ...
Insider Monkey

Biogen Advances Once-Yearly SMA Therapy Salanersen to Phase 3 After Positive Phase 1 Results

Biogen Inc. (NASDAQ:BIIB) is one of the most undervalued US stocks according to analysts. On June 25, Biogen announced positive topline results from an interim analysis of its Phase 1 study for ...
CNN

New Results From Landmark NURTURE Study Show That Pre-Symptomatic SMA Patients Treated With SPINRAZA® (nusinersen) Continue to Demonstrate Sustained Benefit From Treatment

After up to 4.8 years of continuous treatment with SPINRAZA, 100 percent of children treated pre-symptomatically were alive, and none require permanent ventilation Patients continued to maintain and ...