# GILD PDUFA Calendar: FDA Decision Dates & Catalyst Timeline Canonical URL: https://biopharmsignal.com/pdufa-calendar/GILD Company: Gilead Sciences BioPharmSignal tracks active PDUFA and FDA decision milestones associated with GILD. ## GILD PDUFA Milestones - 2024-02-23 — FDA Approval — FDA approved application. FDA recorded approval of BIKTARVY on February 23, 2024. This list-only historical record is sourced from the official FDA applicati... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210251 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/biktarvy-nda-210251-suppl-18.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/february (February 2024) - 2024-02-28 — FDA Approval — FDA approved application. FDA recorded approval of VEKLURY on February 28, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214787 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/veklury-nda-214787-suppl-26.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/february (February 2024) - 2024-03-27 — FDA Approval — FDA approved application. FDA recorded approval of VEMLIDY on March 27, 2024. This list-only historical record is sourced from the official FDA application d... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208464 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/vemlidy-nda-208464-suppl-16.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024) - 2024-04-24 — FDA Approval — FDA approved application. FDA recorded approval of BIKTARVY on April 24, 2024. This list-only historical record is sourced from the official FDA application... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210251 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/biktarvy-nda-210251-suppl-19.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/april (April 2024) - 2024-08-14 — FDA Approval — FDA approved application. FDA recorded approval of LIVDELZI on August 14, 2024. This list-only historical record is sourced from the official FDA application... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217899 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/livdelzi-nda-217899-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-11-25 — FDA Approval — FDA approved application. FDA recorded approval of SUNLENCA on November 25, 2024. This list-only historical record is sourced from the official FDA applicati... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215973 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/sunlenca-nda-215973-suppl-6.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/november (November 2024) - 2025-02-19 — FDA Approval — FDA approved application. FDA recorded approval of ODEFSEY on February 19, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208351 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/odefsey-nda-208351-suppl-14.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/february (February 2025) - 2025-06-18 — FDA Approval — FDA approved application. FDA recorded approval of YEZTUGO on June 18, 2025. This list-only historical record is sourced from the official FDA application da... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220018 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/yeztugo-nda-220018-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-06-20 — FDA Approval — FDA approved application. FDA recorded approval of DESCOVY on June 20, 2025. This list-only historical record is sourced from the official FDA application da... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208215 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/descovy-nda-208215-suppl-23.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-06-20 — FDA Approval — FDA approved application. FDA recorded approval of TYBOST on June 20, 2025. This list-only historical record is sourced from the official FDA application dat... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203094 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/tybost-nda-203094-suppl-18.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-07-30 — FDA Approval — FDA approved application. FDA recorded approval of BIKTARVY on July 30, 2025. This list-only historical record is sourced from the official FDA application d... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210251 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/biktarvy-nda-210251-suppl-23.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/july (July 2025) - 2026-02-05 — FDA Approval — FDA approved application. FDA recorded approval of YESCARTA (axicabtagene ciloleucel) on February 5, 2026. This list-only historical record is sourced from t... Company: Gilead Sciences Source: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2026-biological-license-application-supplement-noteworthy-approvals Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/yescarta-axicabtagene-ciloleucel-yescarta-label-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/february (February 2026) - 2026-05-22 — FDA Approval — FDA approved application. FDA recorded approval of HEPCLUDEX on May 22, 2026. This list-only historical record is sourced from the official FDA application d... Company: Gilead Sciences Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761468 Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/hepcludex-bla-761468-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/may (May 2026) ## Related Pages - Company page: https://biopharmsignal.com/company/GILD - Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar ## FAQ ### What does the GILD PDUFA calendar show? It shows active PDUFA and FDA decision milestones associated with GILD, including decision dates, application stage, and summary details when available. ### Where can I find more context for GILD? Use the BioPharmSignal company page for GILD to read related news, stock data, sector context, and company-specific updates. ### Are these dates investment advice? No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.