Novartis received FDA approval for Rhapsido (remibrutinib), the first oral Bruton’s tyrosine kinase (BTK) inhibitor indicated as a second-line treatment for chronic spontaneous urticaria (CSU). The twice-daily oral pill inhibits histamine release, offering a novel mechanism of action with ease of administration over injectables. This marks the second new CSU drug approval in 2025, following Regeneron's Dupixent. Additional trials are underway to evaluate Rhapsido’s potential in other immunological indications.