Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
Bictegravir 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.
FDA approval tracked on pdufa.bio: HIV (approved Aug 27, 2026). Earlier approvals may not be listed here; the FDA label is the full record. 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.
When is Bictegravir's next FDA decision or readout?
No upcoming catalyst is on our calendar for Bictegravir; 1 FDA decision is on record below.
What happened at Bictegravir'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 used for?
In our records Bictegravir is FDA-approved for HIV (approved Aug 27, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Who makes Bictegravir?
Gilead Sciences, Inc. (GILD).
Has Bictegravir been approved by the FDA?
Yes. The FDA approved an application for Bictegravir 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.
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