pdufa.bio

TREMFYA (guselkumab)

Page updated ·next FDA decision on the calendar ·Data as of Nov 12, 2026 2:24 AM ET

The FDA approved TREMFYA (guselkumab) on May 29, 2026. 4 FDA decisions on record below. Every date links its source.

JNJ catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 4 catalyst events for this program: 0 upcoming and 4 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

FDA decision · Mar 20, 2025 ✓ ApprovedJNJFDA decision · Sep 19, 2025 ✓ ApprovedJNJFDA decision · Sep 29, 2025 ✓ ApprovedJNJFDA decision · May 29, 2026 ✓ ApprovedJNJ

Questions

When is TREMFYA (guselkumab)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for TREMFYA (guselkumab); 4 FDA decisions are on record below.

What happened at TREMFYA (guselkumab)'s most recent FDA decision?

On May 29, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has TREMFYA (guselkumab) been approved by the FDA?

Yes. The FDA approved an application for TREMFYA (guselkumab) on May 29, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.