pdufa.bio

MAVYRET

Updated ยทnext FDA decision on the calendar

MAVYRET 2 FDA decisions on record below. Every date links its source.

ABBV catalyst hub · ENTA catalyst hub

About this program

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

PDUFA · Jun 11, 2025 ✓ ApprovedABBVPDUFA · Jun 11, 2025 ✓ ApprovedENTA

Questions

When is MAVYRET's next FDA decision or readout?

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

What happened at MAVYRET's most recent FDA decision?

On Jun 11, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has MAVYRET been approved by the FDA?

Yes. The FDA approved an application for MAVYRET on Jun 11, 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.