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Drug Approval Process

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

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