pdufa.bio

GILD FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

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 48 daysAnito-cel (anitocabtagene autoleucel)Feb 2, 2027 in 89 daysYeztugo (lenacapavir) once-weekly oral

Decided

Aug 27, 2026 ✓ ApprovedBixlenvo (bictegravir/lenacapavir)Jun 24, 2026 ✓ ApprovedTrodelvy (sacituzumab govitecan-hziy)May 26, 2026 ✓ ApprovedHepcludex (Bulevirtide)Feb 6, 2026 ✓ ApprovedYESCARTA - Axicabtagene ciloleucelDec 16, 2025 ✓ ApprovedExdensurJun 18, 2025 ✓ ApprovedYeztugo