pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro

GILD FDA decision dates

Updated ยทnext FDA decision on the calendar

GILD has 2 upcoming FDA decision dates; the nearest is Dec 23, 2026 for Anito-cel (anitocabtagene autoleucel). 6 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

GILD catalyst hub · full calendar

Upcoming

Dec 23, 2026 in 98 daysAnito-cel (anitocabtagene autoleucel)Feb 2, 2027 in 139 daysYeztugo (lenacapavir) once-weekly oral

Decided

Aug 27, 2026 ✓ ApprovedBixlenvo (bictegravir/lenacapavir)Jun 24, 2026 ✓ ApprovedTrodelvy (sacituzumab govitecaMay 26, 2026 ✓ ApprovedHepcludex (Bulevirtide) - (MYRFeb 6, 2026 ✓ ApprovedYESCARTA - Axicabtagene ciloleDec 16, 2025 ✓ ApprovedExdensurJun 18, 2025 ✓ ApprovedYeztugo
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

Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.

Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.

© 2026 pdufa.bio. All rights reserved.