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FDA Approves Rhapsido Following Rare Pediatric Disease Voucher Redemption
January 21, 2026
WASHINGTON, Jan. 21 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the approval of Rhapsido, also known as remibrutinib, marking the successful redemption of a rare pediatric disease priority review voucher. The decision follows a regulatory process designed to encourage the development of treatments for conditions affecting children.

Under section 529 of the Federal Food, Drug, and Cosmetic Act, the agency manages a program that a . . .

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