pdufa.bio

Primary-sourced

Updated ยทnext FDA decision on the calendar

Primary-sourced 4 FDA decisions on record below. Every date links its source.

ABBV catalyst hub · ETON catalyst hub · INVA catalyst hub · SNY catalyst hub

About this program

We track 4 catalyst events for this program: 0 upcoming and 4 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 · Feb 17, 2026 ✓ ApprovedINVAPDUFA · Feb 20, 2026 ✓ ApprovedABBVPDUFA · Feb 24, 2026 ✓ ApprovedSNYPDUFA · Feb 25, 2026 ✓ ApprovedETON

Questions

When is Primary-sourced's next FDA decision or readout?

No upcoming catalyst is on our calendar for Primary-sourced; 4 FDA decisions are on record below.

What happened at Primary-sourced's most recent FDA decision?

On Feb 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Primary-sourced been approved by the FDA?

Yes. The FDA approved an application for Primary-sourced on Feb 25, 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.