TreatmentsJan 13, 2026
High-Dose Regimen of nusinersen receives European Commission Approval for the treatment of SMA
High-Dose Regimen of nusinersen receives European Commission Approval for the treatment of SMA.
SMA Newsroom
TreatmentsNov 25, 2025
Breaking news: FDA approval for Itvisma® (onasemnogene abeparvovec-brve), the intrathecal formulation of onasemnogene abeparvovec.
Today, Novartis announced that the company has received the FDA approval for Itvisma® (onasemnogene abeparvovec-brve), the intrathecal formulation of onasemnogene abeparvovec, to treat SMA in adult and pediatric patients 2 years of age and older with a confirmed mutation in SMN1.
EUPESMA 2023 Survey Results
We’re thrilled to share the latest publication in SMA Europe’s One Goal editorial series!
Nov 17, 2025
Community Update on the positive decision by EMA regarding the high-dose regimen of nusinersen in the treatment of SMA.
Biogen announced that the high dose regimen of nusinersen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).