pdufa.bio

ZYCUBO (copper histidinate)

Updated ยทnext FDA decision on the calendar

ZYCUBO (copper histidinate) 1 FDA decision on record below. Every date links its source.

FBIO catalyst hub

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 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 13, 2026 ✓ ApprovedFBIO

Questions

When is ZYCUBO (copper histidinate)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for ZYCUBO (copper histidinate); 1 FDA decision is on record below.

What happened at ZYCUBO (copper histidinate)'s most recent FDA decision?

On Jan 13, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has ZYCUBO (copper histidinate) been approved by the FDA?

Yes. The FDA approved an application for ZYCUBO (copper histidinate) on Jan 13, 2026; 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.