>
pdufa.bio

iberdomide

Updated ยทnext FDA decision on the calendar

iberdomide is a Bristol-Myers Squibb Company program in Relapsed/refractory multiple myeloma (RRMM). The FDA approved it on Aug 13, 2026. 1 FDA decision on record below. Every date links its source.

BMY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

iberdomide is marketed as ZENBEXUS (iberdomide); the events below include those tracked under the brand name. Indication under review: Relapsed/refractory multiple myeloma (RRMM). Sponsor: Bristol-Myers Squibb Company (BMY). Market-cap tier at the time we tracked it: Large. 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 · Aug 13, 2026 ✓ ApprovedBMYPDUFA · Aug 17, 2026BMY

Questions

When is iberdomide's next FDA decision or readout?

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

What happened at iberdomide's most recent FDA decision?

On Aug 13, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is iberdomide used for?

In our records iberdomide is under review or in development for Relapsed/refractory multiple myeloma (RRMM).

Who makes iberdomide?

Bristol-Myers Squibb Company (BMY).

Has iberdomide been approved by the FDA?

Yes. The FDA approved an application for iberdomide on Aug 13, 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.