The U.S. Food and Drug Administration (FDA) approved a supplemental application for Tremfya (guselkumab) on September 26, 2025. This approval, identified as BLA 761061 S-28, pertains to an update regarding the drug's efficacy.
Background
Guselkumab, known by its brand name Tremfya, is a biologic medication. This supplemental approval from the FDA specifically addresses an update related to the drug's efficacy profile.
What this means
This supplemental approval for Tremfya (guselkumab) signifies an update to the drug's efficacy profile as recognized by the FDA. Clinicians and researchers will need to consult the full updated label for specific details regarding any new indications, expanded populations, or modified efficacy data that this supplemental application addresses.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) on September 26, 2025. Details are available on the accessdata.fda.gov website, referencing BLA 761061.