Sanofi's MS Drug Faces Setbacks, Delay in Approval
Update: 2025-12-15
Description
Sanofis experimental MS drug, tolebrutinib, faces setbacks; late-stage study for one form fails, US regulators delay decision for another. Despite high sales projections, Sanofi wont pursue approval for primary progressive MS. Confidence remains for non-relapsing secondary progressive MS, with FDA review extended and patients gaining access through special program.
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