pdufa.bio

TEZSPIRE (tezepelumab-ekko)

Updated ยทnext FDA decision on the calendar

TEZSPIRE (tezepelumab-ekko) 2 FDA decisions on record below. Every date links its source.

AMGN catalyst hub · AZN 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 · Oct 17, 2025 ✓ ApprovedAMGNPDUFA · Oct 17, 2025 ✓ ApprovedAZN

Questions

When is TEZSPIRE (tezepelumab-ekko)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for TEZSPIRE (tezepelumab-ekko); 2 FDA decisions are on record below.

What happened at TEZSPIRE (tezepelumab-ekko)'s most recent FDA decision?

On Oct 17, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has TEZSPIRE (tezepelumab-ekko) been approved by the FDA?

Yes. The FDA approved an application for TEZSPIRE (tezepelumab-ekko) on Oct 17, 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.