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Garadacimab

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET

Garadacimab The FDA approved it on Jun 17, 2025. 2 FDA decisions on record below. Every date links its source.

CSLLY catalyst hub · HOTH catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Garadacimab is marketed as Andembry (garadacimab-gxii); the events below include those tracked under the brand name. We track 2 catalyst events for this program: 0 upcoming and 2 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

FDA decision · Jun 16, 2025 ✓ ApprovedHOTHFDA decision · Jun 17, 2025 ✓ ApprovedCSLLY

Questions

When is Garadacimab's next FDA decision or readout?

No upcoming catalyst is on our calendar for Garadacimab; 2 FDA decisions are on record below.

What happened at Garadacimab's most recent FDA decision?

On Jun 17, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Garadacimab been approved by the FDA?

Yes. The FDA approved an application for Garadacimab on Jun 17, 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.