pdufa.bio

IMAAVY

Updated ยทnext FDA decision on the calendar

IMAAVY 1 FDA decision on record below. Every date links its source.

JNJ catalyst hub

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 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 30, 2025 ✓ ApprovedJNJ

Questions

When is IMAAVY's next FDA decision or readout?

No upcoming catalyst is on our calendar for IMAAVY; 1 FDA decision is on record below.

What happened at IMAAVY's most recent FDA decision?

On Apr 30, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has IMAAVY been approved by the FDA?

Yes. The FDA approved an application for IMAAVY on Apr 30, 2025; 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.