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Drug Approval Process

Market Dynamics Clinical Trials New Drug Applications Priority Review Vouchers Sanofi Priority Review

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS

The program narrows to non‑relapsing secondary progressive MS, with the U.S. decision now expected by the end of the first quarter of 2026.

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions