# BMY PDUFA Calendar: FDA Decision Dates & Catalyst Timeline Canonical URL: https://biopharmsignal.com/pdufa-calendar/BMY Company: BMYBristol-Myers Squibb Company BioPharmSignal tracks active PDUFA and FDA decision milestones associated with BMY. ## BMY PDUFA Milestones - 2024-01-26 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on January 26, 2024. This list-only historical record is sourced from the official FDA application... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-122.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/january (January 2024) - 2024-03-06 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on March 6, 2024. This list-only historical record is sourced from the official FDA application dat... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-125.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024) - 2024-03-14 — FDA Approval — FDA approved application. FDA recorded approval of BREYANZI (lisocabtagene maraleucel) on March 14, 2024. This list-only historical record is sourced from th... Company: BMYBristol-Myers Squibb Company Source: https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-for-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-or-Small-Lymphocytic-Lymphoma/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/breyanzi-lisocabtagene-maraleucel-breyanzi-cll-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024) - 2024-04-04 — FDA Approval — FDA approved application. FDA recorded approval of ABECMA (idecabtagene vicleucel) on April 4, 2024. This list-only historical record is sourced from the off... Company: BMYBristol-Myers Squibb Company Source: https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-and-2seventys-Abecma-idecabtagene-vicleucel-for-Triple-Class-Exposed-Relapsed-or-Refractory-Multiple-Myeloma-After-Two-Prior-Lines/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/abecma-idecabtagene-vicleucel-abecma-earlier-lines-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/april (April 2024) - 2024-05-15 — FDA Approval — FDA approved application. FDA recorded approval of BREYANZI (lisocabtagene maraleucel) on May 15, 2024. This list-only historical record is sourced from the... Company: BMYBristol-Myers Squibb Company Source: https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-for-Relapsed-or-Refractory-Follicular-Lymphoma/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/breyanzi-lisocabtagene-maraleucel-breyanzi-fl-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/may (May 2024) - 2024-05-30 — FDA Approval — FDA approved application. FDA recorded approval of BREYANZI (lisocabtagene maraleucel) on May 30, 2024. This list-only historical record is sourced from the... Company: BMYBristol-Myers Squibb Company Source: https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/breyanzi-lisocabtagene-maraleucel-breyanzi-mcl-sbla.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/may (May 2024) - 2024-06-13 — FDA Approval — FDA approved application. FDA recorded approval of AUGTYRO on June 13, 2024. This list-only historical record is sourced from the official FDA application da... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218213 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/augtyro-nda-218213-suppl-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-06-21 — FDA Approval — FDA approved application. FDA recorded approval of KRAZATI on June 21, 2024. This list-only historical record is sourced from the official FDA application da... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216340 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/krazati-nda-216340-suppl-5.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-08-30 — FDA Approval — FDA approved application. FDA recorded approval of ZEPOSIA on August 30, 2024. This list-only historical record is sourced from the official FDA application... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209899 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/zeposia-nda-209899-suppl-11.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-09-26 — FDA Approval — FDA approved application. FDA recorded approval of COBENFY on September 26, 2024. This list-only historical record is sourced from the official FDA applicati... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216158 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/cobenfy-nda-216158-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2024-10-03 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on October 3, 2024. This list-only historical record is sourced from the official FDA application d... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-127.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/october (October 2024) - 2024-12-27 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO QVANTIG on December 27, 2024. This list-only historical record is sourced from the official FDA app... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761381 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-qvantig-bla-761381-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024) - 2025-01-28 — FDA Approval — FDA approved application. FDA recorded approval of YERVOY on January 28, 2025. This list-only historical record is sourced from the official FDA application... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/yervoy-bla-125377-suppl-132.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/january (January 2025) - 2025-04-08 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on April 8, 2025. This list-only historical record is sourced from the official FDA application dat... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-132.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-08 — FDA Approval — FDA approved application. FDA recorded approval of YERVOY on April 8, 2025. This list-only historical record is sourced from the official FDA application dat... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/yervoy-bla-125377-suppl-135.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-11 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on April 11, 2025. This list-only historical record is sourced from the official FDA application da... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-129.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-11 — FDA Approval — FDA approved application. FDA recorded approval of YERVOY on April 11, 2025. This list-only historical record is sourced from the official FDA application da... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/yervoy-bla-125377-suppl-133.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-17 — FDA Approval — FDA approved application. FDA recorded approval of CAMZYOS on April 17, 2025. This list-only historical record is sourced from the official FDA application d... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214998 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/camzyos-nda-214998-suppl-10.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-17 — FDA Approval — FDA approved application. FDA recorded approval of ELIQUIS on April 17, 2025. This list-only historical record is sourced from the official FDA application d... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202155 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/eliquis-nda-202155-suppl-40.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-04-17 — FDA Approval — FDA approved application. FDA recorded approval of ELIQUIS SPRINKLE / ELIQUIS on April 17, 2025. This list-only historical record is sourced from the officia... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220073 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/eliquis-sprinkle-eliquis-nda-220073-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025) - 2025-05-23 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on May 23, 2025. This list-only historical record is sourced from the official FDA application data... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-133.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025) - 2025-05-23 — FDA Approval — FDA approved application. FDA recorded approval of YERVOY on May 23, 2025. This list-only historical record is sourced from the official FDA application data... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125377 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/yervoy-bla-125377-suppl-136.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/may (May 2025) - 2025-10-27 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO QVANTIG on October 27, 2025. This list-only historical record is sourced from the official FDA appl... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761381 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-qvantig-bla-761381-suppl-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025) - 2025-11-24 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO QVANTIG on November 24, 2025. This list-only historical record is sourced from the official FDA app... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761381 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-qvantig-bla-761381-suppl-5.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/november (November 2025) - 2026-03-06 — FDA Approval — FDA approved application. FDA recorded approval of SOTYKTU on March 6, 2026. This list-only historical record is sourced from the official FDA application da... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214958 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/sotyktu-nda-214958-suppl-2.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026) - 2026-03-20 — FDA Approval — FDA approved application. FDA recorded approval of OPDIVO on March 20, 2026. This list-only historical record is sourced from the official FDA application da... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/opdivo-bla-125554-suppl-135.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/march (March 2026) - 2026-04-09 — FDA Approval — FDA approved application. FDA recorded approval of ONUREG on April 9, 2026. This list-only historical record is sourced from the official FDA application dat... Company: BMYBristol-Myers Squibb Company Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214120 Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/onureg-nda-214120-suppl-3.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-08-17 — PDUFA — Original PDUFA date superseded by early approval. FDA had assigned August 17 as the target action date for the iberdomide combination NDA. The agency granted... Company: BMYBristol-Myers Squibb Company Source: https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Iberdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/iberdomide-relapsed-refractory-multiple-myeloma.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026) - 2026-09-30 — PDUFA — FDA decision expected. FDA assigned a September 30, 2026 PDUFA date to the CAMZYOS sNDA for adolescents with symptomatic obstructive hypertrophic cardiomyopa... Company: BMYBristol-Myers Squibb Company Source: https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-for-Camzyos-mavacamten-to-Treat-Adolescents-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/BMY/camzyos-adolescent-obstructive-hypertrophic-cardiomyopathy.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/september (September 2026) ## Related Pages - Company page: https://biopharmsignal.com/company/BMY - Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar ## FAQ ### What does the BMY PDUFA calendar show? It shows active PDUFA and FDA decision milestones associated with BMY, including decision dates, application stage, and summary details when available. ### Where can I find more context for BMY? Use the BioPharmSignal company page for BMY 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.