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Bictegravir and

Updated ยทnext FDA decision on the calendar

Bictegravir and is a Gilead Sciences, Inc. program in HIV. The FDA approved it on Aug 27, 2026. 1 FDA decision on record below. Every date links its source.

GILD catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: HIV. Sponsor: Gilead Sciences, Inc. (GILD). Market-cap tier at the time we tracked it: Large. 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 · Aug 27, 2026 ✓ ApprovedGILD

Questions

When is Bictegravir and's next FDA decision or readout?

No upcoming catalyst is on our calendar for Bictegravir and; 1 FDA decision is on record below.

What happened at Bictegravir and's most recent FDA decision?

On Aug 27, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Bictegravir and used for?

In our records Bictegravir and is under review or in development for HIV.

Who makes Bictegravir and?

Gilead Sciences, Inc. (GILD).

Has Bictegravir and been approved by the FDA?

Yes. The FDA approved an application for Bictegravir and on Aug 27, 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.