anitocabtagene autoleucel ("anito-cel") — PDUFA
Dec 23
Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.Source filing
GILD biotech catalysts & pipeline
GILEAD SCIENCES INC · Data as of 2026-09-08
Upcoming catalysts
Yeztugo (lenacapavir) — Filing acceptance
Feb 2
Announced U.S. Food and Drug Administration ("FDA") accepted a supplemental New Drug Application submission for Yeztugo® (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis ("PrEP"), with a Prescription Drug User Fee Act target action date of February 2, 2027.Source filing