Spinraza
Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information
Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission
Biogen Ushers Spinraza Follow-Up (Salanersen) Into Pivotal SMA Studies
Biogen; SMA; Spinraza; salanersen; Phase III; clinical trials; neurodegeneration; motor milestones; pediatric; Novartis Zolgensma; ASO therapy
Biogen’s Higher Dose Spinraza Shows Enhanced Efficacy in Treating Spinal Muscular Atrophy
Biogen, Spinraza, Nusinersen, Spinal Muscular Atrophy (SMA), Higher Dose Regimen, Clinical Trial Results, DEVOTE Study, Motor Function Improvement, Neurodegeneration Reduction
Biogen Announces Positive Results from Higher Dose Spinraza Study in Spinal Muscular Atrophy Patients
Biogen, Spinraza, spinal muscular atrophy, SMA, higher dose, clinical trial, DEVOTE study