SMA Newsroom

ResearchTreatmentsClinical trialsMay 31, 2022

Roche Community Update: FDA (U.S. Food and Drug Administration) approves a label expansion for risdiplam

Today, the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). This means that risdiplam is now approved in the US to treat SMA in children and adults of all ages. 

Roche provides us with a summary of 2021 activities

Following our request for regular updates, Roche has shared an overview of their work in the community over the past year and a summary of progress in advancing research and increasing access to risdiplam in Europe and beyond.