pdufa.bio

DUPIXENT (dupilumab)

Updated ยทnext FDA decision on the calendar

DUPIXENT (dupilumab) 2 FDA decisions on record below. Every date links its source.

REGN catalyst hub · SNY catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 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

PDUFA · Apr 22, 2026 ✓ ApprovedREGNPDUFA · Apr 22, 2026 ✓ ApprovedSNY

Questions

When is DUPIXENT (dupilumab)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for DUPIXENT (dupilumab); 2 FDA decisions are on record below.

What happened at DUPIXENT (dupilumab)'s most recent FDA decision?

On Apr 22, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.