# MRK PDUFA Calendar: FDA Decision Dates & Catalyst Timeline Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRK Company: Merck BioPharmSignal tracks active PDUFA and FDA decision milestones associated with MRK. ## MRK PDUFA Milestones - 2024-01-12 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on January 12, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-147.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/january (January 2024) - 2024-01-25 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on January 25, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-124.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/january (January 2024) - 2024-03-26 — FDA Approval — FDA approved application. FDA recorded approval of WINREVAIR on March 26, 2024. This list-only historical record is sourced from the official FDA application... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761363 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/winrevair-bla-761363-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024) - 2024-06-07 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on June 7, 2024. This list-only historical record is sourced from the official FDA application da... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-154.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-06-17 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on June 17, 2024. This list-only historical record is sourced from the official FDA application d... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-155.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-08-07 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on August 7, 2024. This list-only historical record is sourced from the official FDA application... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-157.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-08-30 — FDA Approval — FDA approved application. FDA recorded approval of PREVYMIS on August 30, 2024. This list-only historical record is sourced from the official FDA application... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209939 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/prevymis-nda-209939-suppl-13.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-09-17 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on September 17, 2024. This list-only historical record is sourced from the official FDA applicat... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-161.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2024-12-11 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on December 11, 2024. This list-only historical record is sourced from the official FDA applicati... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-162.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024) - 2024-12-12 — FDA Approval — FDA approved application. FDA recorded approval of BRIDION on December 12, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=22225 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/bridion-nda-022225-suppl-14.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024) - 2025-01-28 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on January 28, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-172.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/january (January 2025) - 2025-03-19 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on March 19, 2025. This list-only historical record is sourced from the official FDA application... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-170.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/march (March 2025) - 2025-04-15 — FDA Approval — FDA approved application. FDA recorded approval of WELIREG on April 15, 2025. This list-only historical record is sourced from the official FDA application d... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215383 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/welireg-nda-215383-suppl-11.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-21 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on April 21, 2025. This list-only historical record is sourced from the official FDA application... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-174.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-05-14 — FDA Approval — FDA approved application. FDA recorded approval of WELIREG on May 14, 2025. This list-only historical record is sourced from the official FDA application dat... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215383 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/welireg-nda-215383-suppl-12.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025) - 2025-05-22 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on May 22, 2025. This list-only historical record is sourced from the official FDA application da... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-182.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025) - 2025-06-03 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on June 3, 2025. This list-only historical record is sourced from the official FDA application da... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-173.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-06-06 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on June 6, 2025. This list-only historical record is sourced from the official FDA application da... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-183.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-06-09 — FDA Approval — FDA approved application. FDA recorded approval of ENFLONSIA on June 9, 2025. This list-only historical record is sourced from the official FDA application d... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761432 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/enflonsia-bla-761432-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-06-12 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on June 12, 2025. This list-only historical record is sourced from the official FDA application d... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-180.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-07-24 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on July 24, 2025. This list-only historical record is sourced from the official FDA application d... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-178.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/july (July 2025) - 2025-09-19 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA QLEX on September 19, 2025. This list-only historical record is sourced from the official FDA app... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761467 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-qlex-bla-761467-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/september (September 2025) - 2025-10-15 — FDA Approval — FDA approved application. FDA recorded approval of FDA application BLA 761495 on October 15, 2025. This list-only historical record is sourced from the offic... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761495 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/fda-application-bla-761495-bla-761495-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025) - 2025-10-24 — FDA Approval — FDA approved application. FDA recorded approval of WINREVAIR on October 24, 2025. This list-only historical record is sourced from the official FDA applicati... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761363 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/winrevair-bla-761363-suppl-7.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025) - 2025-11-21 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on November 21, 2025. This list-only historical record is sourced from the official FDA applicati... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-188.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/november (November 2025) - 2025-11-21 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA QLEX on November 21, 2025. This list-only historical record is sourced from the official FDA appl... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761467 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-qlex-bla-761467-suppl-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/november (November 2025) - 2025-12-09 — FDA Approval — FDA approved application. FDA recorded approval of RECARBRIO on December 9, 2025. This list-only historical record is sourced from the official FDA applicati... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212819 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/recarbrio-nda-212819-suppl-8.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/december (December 2025) - 2026-01-27 — FDA Approval — FDA approved application. FDA recorded approval of NOXAFIL on January 27, 2026. This list-only historical record is sourced from the official FDA application... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205053 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/noxafil-nda-205053-suppl-18.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/january (January 2026) - 2026-01-27 — FDA Approval — FDA approved application. FDA recorded approval of NOXAFIL POWDERMIX KIT on January 27, 2026. This list-only historical record is sourced from the official F... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214770 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/noxafil-powdermix-kit-nda-214770-suppl-9.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/january (January 2026) - 2026-02-10 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA on February 10, 2026. This list-only historical record is sourced from the official FDA applicati... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-bla-125514-suppl-186.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/february (February 2026) - 2026-02-10 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA QLEX on February 10, 2026. This list-only historical record is sourced from the official FDA appl... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761467 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-qlex-bla-761467-suppl-2.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/february (February 2026) - 2026-04-20 — FDA Approval — FDA approved application. FDA recorded approval of IDVYNSO on April 20, 2026. This list-only historical record is sourced from the official FDA application d... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216964 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/idvynso-idvynso-nda.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-04-24 — FDA Approval — FDA approved application. FDA recorded approval of KEYTRUDA QLEX on April 24, 2026. This list-only historical record is sourced from the official FDA applica... Company: Merck Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761467 Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-qlex-bla-761467-suppl-3.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-06-19 — PDUFA — FDA approved WELIREG plus KEYTRUDA. FDA approved belzutifan with pembrolizumab or KEYTRUDA QLEX as adjuvant treatment for adults with clear cell renal cell c... Company: Merck Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/welireg-keytruda-adjuvant-clear-cell-rcc.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/june (June 2026) - 2026-08-17 — PDUFA — Original PDUFA date superseded by early approval. FDA had assigned August 17 as the target action date for the supplemental applications. The agency approved... Company: Merck Source: https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/ Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/keytruda-padcev-muscle-invasive-bladder-cancer.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026) - 2026-09-21 — PDUFA — FDA decision expected. FDA assigned a September 21, 2026 PDUFA date to the HYPERION-based WINREVAIR label-update application. Company: Merck Source: https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/ Event detail: https://biopharmsignal.com/pdufa-calendar/MRK/winrevair-recently-diagnosed-pah-hyperion.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/september (September 2026) ## Related Pages - Company page: https://biopharmsignal.com/company/MRK - Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar ## FAQ ### What does the MRK PDUFA calendar show? It shows active PDUFA and FDA decision milestones associated with MRK, including decision dates, application stage, and summary details when available. ### Where can I find more context for MRK? Use the BioPharmSignal company page for MRK 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.