September FDA approvals include first BTK inhibitor for chronic spontaneous urticaria

FDA approved Rhapsido remirbutinib to treat chronic spontaneous urticaria on Sept. 30, making it the first Bruton’s tyrosine kinase (Btk) inhibitor for the inflammatory skin condition, and among the earliest Btk approvals in any I&I indication, after more than a decade as an oncology target. Novartis AG (SIX:NOVN; NYSE:NVS) is also developing Rhapsido for hidradenitis suppurativa and food allergy.

Rhapsidio became the 32nd new molecular entity approved by FDA in 2025. After a slow start to the year, the agency closed 3Q only two behind the 34 approvals through Sept. 30 of last year. 2024 went on to a total of 50, a tie for the fourth most approvals since FDA began publishing data in 1985...