Novartis has recently announced that its intrathecal (IT) formulation of onasemnogene abeparvovec (OAV101 IT) successfully achieved the primary endpoint in a Phase III STEER study (NCT05089656) ...
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Novartis has recently announced that its intrathecal (IT) formulation of onasemnogene abeparvovec (OAV101 IT) successfully ...
The Phase 3 STEER trial enrolled more than 100 children with SMA type 2, ages 2-17, who were able to sit, but hadn't walked ...
Analysis of Biogen's stock performance in 2024, focusing on sales struggles, financial health, and valuation. Read more here.
Novartis reported that its intrathecal (IT) formulation of onasemnogene abeparvovec (OAV101 IT) reached its primary endpoint in a Phase III study in paediatric patients aged two to 17 with type II ...
More than three years after Novartis’ plan for a speedy approval for intrathecal Zolgensma was thwarted by an FDA requirement ...
Novartis is in the trial phase for a new experimental medicine that has shown promise in improving motor function in children with a form of spinal muscular atrophy, according to a Dec. 30 report from ...
The firm said it plans to share data with regulatory agencies from the Phase III STEER trial after it met its primary endpoint.
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Now, Novartis hopes to be able to share the data with regulatory authorities in 2025, including the US FDA, in the hope of ...
The Swiss drugmaker's one-time therapy, branded as Zolgensma, is already approved in the US to treat children less than 2 ...