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FDA Approves Tremfya (Guselkumab) for Rare Pediatric Disease Priority Review Voucher Redemption
April 19, 2025
WASHINGTON, April 19 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has announced the approval of TREMFYA (guselkumab) for the redemption of a rare pediatric disease priority review voucher.

The approval, which was granted on March 20, 2025, follows the successful submission of supplemental application Supplement-24 by the manufacturer. This approval confirms that TREMFYA meets the necessary criteria to redeem the voucher, which incen . . .

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