pdufa.bio

Fabhalta (iptacopan)

Updated ยทnext FDA decision on the calendar

Fabhalta (iptacopan) 1 FDA decision on record below. Every date links its source.

NVS 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 · Mar 20, 2025 ✓ ApprovedNVS

Questions

When is Fabhalta (iptacopan)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Fabhalta (iptacopan); 1 FDA decision is on record below.

What happened at Fabhalta (iptacopan)'s most recent FDA decision?

On Mar 20, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Fabhalta (iptacopan) been approved by the FDA?

Yes. The FDA approved an application for Fabhalta (iptacopan) on Mar 20, 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.