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The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS).

Investigational tolebrutinib slowed disability progression in people with non-relapsing secondary progressive multiple sclerosis (SPMS), the phase III HERCULES trial showed. The Bruton's tyrosine ...

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The HERCULES study of tolebrutinib is the first and only to show reduced confirmed disability progression at 6 months in nonrelapsing secondary progressive multiple sclerosis (MS). The HERCULES ...

– Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 – – Additional Data from Phase 2 CALLIPER Trial in ...

Findings showed the study met its primary endpoint demonstrating a reduction in disability accumulation with tolebrutinib compared with placebo. Tolebrutinib was found to delay disability progression ...

– Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) ...

- FENhance 1 is the final study readout of the fenebrutinib pivotal clinical development program in MS, following positive results for FENhance 2 in RMS and for FENtrepid in primary progressive ...

- FENhance 1 met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses by 51% compared to teriflunomide in relapsing multiple sclerosis (RMS), consistent with ...