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pdufa.bio

Tezepelumab

Updated ยทnext FDA decision on the calendar

Tezepelumab is a Amgen Inc program. The FDA approved it on Oct 17, 2025. 2 FDA decisions on record below. Every date links its source.

AMGN catalyst hub · AZN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Tezepelumab is marketed as TEZSPIRE (tezepelumab-ekko); the events below include those tracked under the brand name. Sponsor: Amgen Inc (AMGN, AZN). 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 17, 2025 ✓ ApprovedAMGNPDUFA · Oct 17, 2025 ✓ ApprovedAZNReadout · Jul 2026AMGN

Questions

When is Tezepelumab's next FDA decision or readout?

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

What happened at Tezepelumab'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.

Who makes Tezepelumab?

Amgen Inc (AMGN, AZN).

Has Tezepelumab been approved by the FDA?

Yes. The FDA approved an application for Tezepelumab 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.