pdufa.bio

AJOVY (fremanezumab-vfrm)

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

AJOVY (fremanezumab-vfrm) The FDA approved it on Aug 6, 2025. 1 FDA decision on record below. Every date links its source.

TEVA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

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

FDA decision · Aug 6, 2025 ✓ ApprovedTEVA

Questions

When is AJOVY (fremanezumab-vfrm)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for AJOVY (fremanezumab-vfrm); 1 FDA decision is on record below.

What happened at AJOVY (fremanezumab-vfrm)'s most recent FDA decision?

On Aug 6, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has AJOVY (fremanezumab-vfrm) been approved by the FDA?

Yes. The FDA approved an application for AJOVY (fremanezumab-vfrm) on Aug 6, 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.