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pdufa.bio

Imsidolimab

Updated ยทnext FDA decision on the calendar

Imsidolimab is a Vanda Pharmaceuticals Inc. program. Its PDUFA date is Dec 12, 2026, the FDA's goal date to complete review of the application. Every date links its source.

VNDA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Vanda Pharmaceuticals Inc. (VNDA). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 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

PDUFA · Dec 12, 2026VNDA

Questions

When is Imsidolimab's next FDA decision or readout?

Imsidolimab's PDUFA date is Dec 12, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Imsidolimab's most recent FDA decision?

No FDA decision for Imsidolimab is in our archive yet.

Who makes Imsidolimab?

Vanda Pharmaceuticals Inc. (VNDA).

Where does this data come from?

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