# GSK PDUFA Calendar: FDA Decision Dates & Catalyst Timeline Canonical URL: https://biopharmsignal.com/pdufa-calendar/GSK Company: GSK plc BioPharmSignal tracks active PDUFA and FDA decision milestones associated with GSK. ## GSK PDUFA Milestones - 2024-04-05 — FDA Approval — FDA approved application. FDA recorded approval of DOVATO on April 5, 2024. This list-only historical record is sourced from the official FDA application dat... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211994 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/dovato-nda-211994-suppl-18.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/april (April 2024) - 2024-05-16 — FDA Approval — FDA approved application. FDA recorded approval of BENLYSTA on May 16, 2024. This list-only historical record is sourced from the official FDA application da... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761043 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/benlysta-bla-761043-suppl-27.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/may (May 2024) - 2024-06-07 — FDA Approval — FDA approved application. FDA recorded approval of AREXVY on June 7, 2024. This list-only historical record is sourced from the official FDA application data... Company: GSK plc Source: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2024-biological-license-application-supplement-noteworthy-approvals Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/arexvy-arexvy-risk-adults-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-08-01 — FDA Approval — FDA approved application. FDA recorded approval of JEMPERLI on August 1, 2024. This list-only historical record is sourced from the official FDA application... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761174 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/jemperli-bla-761174-suppl-9.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-09-20 — FDA Approval — FDA approved application. FDA recorded approval of APRETUDE on September 20, 2024. This list-only historical record is sourced from the official FDA applicat... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215499 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/apretude-nda-215499-suppl-8.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2024-09-20 — FDA Approval — FDA approved application. FDA recorded approval of CABENUVA KIT on September 20, 2024. This list-only historical record is sourced from the official FDA appl... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212888 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/cabenuva-kit-nda-212888-suppl-15.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2024-09-20 — FDA Approval — FDA approved application. FDA recorded approval of VOCABRIA on September 20, 2024. This list-only historical record is sourced from the official FDA applicat... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212887 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/vocabria-nda-212887-suppl-9.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2025-03-25 — FDA Approval — FDA approved application. FDA recorded approval of BLUJEPA on March 25, 2025. This list-only historical record is sourced from the official FDA application d... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218230 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/blujepa-nda-218230-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/march (March 2025) - 2025-05-22 — FDA Approval — FDA approved application. FDA recorded approval of NUCALA on May 22, 2025. This list-only historical record is sourced from the official FDA application data... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125526 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/nucala-bla-125526-suppl-7.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025) - 2025-06-18 — FDA Approval — FDA approved application. FDA recorded approval of ZEJULA on June 18, 2025. This list-only historical record is sourced from the official FDA application dat... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214876 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/zejula-nda-214876-suppl-3.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-06-20 — FDA Approval — FDA approved application. FDA recorded approval of BENLYSTA on June 20, 2025. This list-only historical record is sourced from the official FDA application d... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761043 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/benlysta-bla-761043-suppl-34.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-10-23 — FDA Approval — FDA approved application. FDA recorded approval of BLENREP on October 23, 2025. This list-only historical record is sourced from the official FDA application... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761440 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/blenrep-bla-761440-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025) - 2025-12-11 — FDA Approval — FDA approved application. FDA recorded approval of BLUJEPA on December 11, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218230 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/blujepa-nda-218230-suppl-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/december (December 2025) - 2025-12-16 — FDA Approval — FDA approved application. FDA recorded approval of EXDENSUR on December 16, 2025. This list-only historical record is sourced from the official FDA applicati... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761458 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/exdensur-bla-761458-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/december (December 2025) - 2026-03-09 — FDA Approval — FDA approved application. FDA recorded approval of WELLCOVORIN on March 9, 2026. This list-only historical record is sourced from the official FDA applicatio... Company: GSK plc Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=18342 Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/wellcovorin-nda-018342-suppl-15.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026) - 2026-03-12 — FDA Approval — FDA approved application. FDA recorded approval of AREXVY on March 12, 2026. This list-only historical record is sourced from the official FDA application da... Company: GSK plc 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/GSK/arexvy-arexvy-adult-expansion-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026) - 2026-03-17 — FDA Approval — FDA approved application. FDA recorded approval of LYNAVOY (linerixibat) on March 17, 2026. This list-only historical record is sourced from the official FDA... Company: GSK plc Source: https://www.gsk.com/en-gb/media/press-releases/lynavoy-linerixibat-approved-by-the-us-fda/ Event detail: https://biopharmsignal.com/pdufa-calendar/GSK/lynavoy-linerixibat-lynavoy-nda.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026) ## Related Pages - Company page: https://biopharmsignal.com/company/GSK - Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar ## FAQ ### What does the GSK PDUFA calendar show? It shows active PDUFA and FDA decision milestones associated with GSK, including decision dates, application stage, and summary details when available. ### Where can I find more context for GSK? Use the BioPharmSignal company page for GSK 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.