Key facts: Novartis gained FDA approval for Rhapsido, the first oral BTK inhibitor for chronic spontaneous urticaria. Regulatory submissions are complete in the EU and Japan, with priority review in China.
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- Novartis gained FDA approval for Rhapsido, the first oral BTK inhibitor for chronic spontaneous urticaria. Regulatory submissions are complete in the EU and Japan, with priority review in China.1
- The U.S. Food and Drug Administration has approved Novartis' oral treatment for a type of chronic inflammatory skin disease, marking a significant regulatory milestone for the company.2
- Novartis shares rose after a 100% tariff on imported branded drugs was announced, backed by the company's $23 billion investment in US operations, offering protection against the tariffs.3