pdufa.bio

Oziltus (denosumab-mobz)

Updated ยทnext FDA decision on the calendar

Oziltus (denosumab-mobz) 1 FDA decision on record below. Every date links its source.

AMRX 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 · Dec 22, 2025 ✓ ApprovedAMRX

Questions

When is Oziltus (denosumab-mobz)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Oziltus (denosumab-mobz); 1 FDA decision is on record below.

What happened at Oziltus (denosumab-mobz)'s most recent FDA decision?

On Dec 22, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Oziltus (denosumab-mobz) been approved by the FDA?

Yes. The FDA approved an application for Oziltus (denosumab-mobz) on Dec 22, 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.