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pdufa.bio

Lurbinectedin

Updated ยทnext FDA decision on the calendar

Lurbinectedin is a Jazz Pharmaceuticals plc program. The FDA approved it on Oct 2, 2025. 2 FDA decisions on record below. Every date links its source.

JAZZ catalyst hub · RHHBY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Lurbinectedin is marketed as Zepzelca (lurbinectedin); the events below include those tracked under the brand name. Sponsor: Jazz Pharmaceuticals plc (JAZZ, RHHBY). We track 3 catalyst events for this program: 0 upcoming and 3 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 · Oct 2, 2025 ✓ ApprovedJAZZPDUFA · Oct 2, 2025 ✓ ApprovedRHHBYReadout · Jul 2026JAZZ

Questions

When is Lurbinectedin's next FDA decision or readout?

No upcoming catalyst is on our calendar for Lurbinectedin; 2 FDA decisions are on record below.

What happened at Lurbinectedin's most recent FDA decision?

On Oct 2, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Lurbinectedin?

Jazz Pharmaceuticals plc (JAZZ, RHHBY).

Has Lurbinectedin been approved by the FDA?

Yes. The FDA approved an application for Lurbinectedin on Oct 2, 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.