Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria

Novartis

30 September 2025 - Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology portfolio.

Novartis announced today that Rhapsido (remibrutinib) received US FDA approval as an oral treatment for adult patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Read Novartis press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration