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US FDA Declines Approval for Biogen's Higher-Dose Spinraza in SMA
The decision was relayed via a ‘complete response letter’ to Biogen, which clarified there were no issues with the clinical data behind the new high-dose regimen. Biogen says it will resubmit the application promptly, drawing on information that is already at hand.
Spinraza | 24/09/2025 | By Darshana | 134
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