Type:Notice
Citation:90 FR 16692
Reading Time:about a minute or two
The Food and Drug Administration (FDA) has announced the approval of a product called TREMFYA (guselkumab) using a priority review voucher. This type of voucher is given by the FDA under the Federal Food, Drug, and Cosmetic Act to sponsors with approved treatments for rare pediatric diseases. The approval of TREMFYA, which was finalized on March 20, 2025, met all necessary criteria for using the voucher. Information on both the priority review voucher program and TREMFYA is available on the FDA's website.
Simple Explanation
The FDA told everyone that a special medicine, TREMFYA, got approved faster because it helps kids with rare illnesses. They used a special ticket to make the approval quicker.