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Bixlenvo (bictegravir/lenacapavir)

Updated ยทnext FDA decision on the calendar

Bixlenvo (bictegravir/lenacapavir) 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

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 Bixlenvo (bictegravir/lenacapavir)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Bixlenvo (bictegravir/lenacapavir); 1 FDA decision is on record below.

What happened at Bixlenvo (bictegravir/lenacapavir)'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.

Has Bixlenvo (bictegravir/lenacapavir) been approved by the FDA?

Yes. The FDA approved an application for Bixlenvo (bictegravir/lenacapavir) 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.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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