FDA approves Rhapsido (remibrutinib) for symptomatic dermographism

The FDA approved remibrutinib (Rhapsido) for adults with symptomatic dermographism inadequately controlled by H1 antihistamines, marking the first approved treatment specifically for this condition. The approval was based on the Phase 3 RemIND trial, which used a single protocol including cohorts for both symptomatic dermographism and chronic spontaneous urticaria, enabling faster and more efficient regulatory submissions.

This Wire brief sits within Fusion42's coverage of Biotech, and 7 sources have reported it between 7 Oct 2026 and 10 Oct 2026.