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pdufa.bio

Zanubrutinib

Updated ยทnext FDA decision on the calendar

Zanubrutinib is a BeOne Medicines Ltd. program. Its next catalyst is a Readout in Dec 2026. Every date links its source.

ONC catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: BeOne Medicines Ltd. (ONC). We track 3 catalyst events for this program: 3 upcoming and 0 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

Readout · Dec 2026ONCReadout · Mar 2027ONCReadout · Oct 2027ONC

Questions

When is Zanubrutinib's next FDA decision or readout?

The next tracked catalyst for Zanubrutinib is a Readout in Dec 2026.

What happened at Zanubrutinib's most recent FDA decision?

No FDA decision for Zanubrutinib is in our archive yet.

Who makes Zanubrutinib?

BeOne Medicines Ltd. (ONC).

Where does this data come from?

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