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Omvoh (mirikizumab-mrkz)

Updated ยทnext FDA decision on the calendar

Omvoh (mirikizumab-mrkz) 2 FDA decisions on record below. Every date links its source.

LLY 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 · Jan 15, 2025 ✓ ApprovedLLYPDUFA · Oct 27, 2025 ✓ ApprovedLLY

Questions

When is Omvoh (mirikizumab-mrkz)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Omvoh (mirikizumab-mrkz); 2 FDA decisions are on record below.

What happened at Omvoh (mirikizumab-mrkz)'s most recent FDA decision?

On Oct 27, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Omvoh (mirikizumab-mrkz) been approved by the FDA?

Yes. The FDA approved an application for Omvoh (mirikizumab-mrkz) on Oct 27, 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.