SCHAUMBURG, Ill., Nov. 26, 2025 /PRNewswire/ -- Cure SMA, the leading nonprofit organization dedicated to supporting those impacted by spinal muscular atrophy (SMA), welcomes the FDA approval of ...
Novartis wins FDA approval for Itvisma, a one-time gene therapy offering broader SMA treatment with sustained motor function ...
Onasemnogene abeparvovec-brve is the first gene replacement therapy approved for SMA patients aged 2 years and older, expanding access beyond infants. Phase 3 trials demonstrated significant motor ...
The FDA has approved Itvisma (onasemnogene abeparvovec-brve) to treat children two years and older, teens, and adults living with spinal muscular atrophy (SMA). It is indicated for patients with a ...
Pharmaceutical Technology on MSN
Novartis secures approval from FDA for Itvisma to treat SMA
The approval is supported by findings from the open-label Phase IIIb STRENGTH study and the Phase III STEER study.
Itvisma, an intrathecal version of Zolgensma, can be used in children, teens and adults to stabilize or improve motor ...
Zacks Investment Research on MSN
FDA Greenlights Novartis' Gene Replacement Treatment for SMA
Novartis NVS obtained FDA approval for onasemnogene abeparvovec-brve, a gene replacement therapy, for children two years and ...
Novartis is on the final straight to approval of its spinal muscular atrophy (SMA) gene therapy Zolgensma in the EU, after getting a recommendation for approval from the CHMP. The positive opinion ...
The U.S. Food and Drug Administration has approved Itvisma as the first gene therapy for spinal muscular atrophy patients ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback