# AZN PDUFA Calendar: FDA Decision Dates & Catalyst Timeline Canonical URL: https://biopharmsignal.com/pdufa-calendar/AZN Company: AstraZeneca PLC BioPharmSignal tracks active PDUFA and FDA decision milestones associated with AZN. ## AZN PDUFA Milestones - 2024-01-24 — FDA Approval — FDA approved application. FDA recorded approval of KOSELUGO on January 24, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213756 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/koselugo-nda-213756-suppl-4.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/january (January 2024) - 2024-01-31 — FDA Approval — FDA approved application. FDA recorded approval of TAGRISSO on January 31, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/tagrisso-nda-208065-suppl-29.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/january (January 2024) - 2024-02-15 — FDA Approval — FDA approved application. FDA recorded approval of ENHERTU on February 15, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-bla-761139-suppl-26.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/february (February 2024) - 2024-02-16 — FDA Approval — FDA approved application. FDA recorded approval of TAGRISSO on February 16, 2024. This list-only historical record is sourced from the official FDA applicati... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/tagrisso-nda-208065-suppl-30.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/february (February 2024) - 2024-03-22 — FDA Approval — FDA approved application. FDA recorded approval of BRILINTA on March 22, 2024. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=22433 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/brilinta-nda-022433-suppl-35.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/march (March 2024) - 2024-04-05 — FDA Approval — FDA approved application. FDA recorded approval of ENHERTU on April 5, 2024. This list-only historical record is sourced from the official FDA application da... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-bla-761139-suppl-28.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/april (April 2024) - 2024-04-05 — FDA Approval — FDA approved application. FDA recorded approval of FASENRA on April 5, 2024. This list-only historical record is sourced from the official FDA application da... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761070 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/fasenra-bla-761070-suppl-20.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/april (April 2024) - 2024-06-12 — FDA Approval — FDA approved application. FDA recorded approval of FARXIGA on June 12, 2024. This list-only historical record is sourced from the official FDA application da... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202293 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/farxiga-nda-202293-suppl-31.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-06-12 — FDA Approval — FDA approved application. FDA recorded approval of XIGDUO XR on June 12, 2024. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205649 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/xigduo-xr-nda-205649-suppl-22.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-06-14 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on June 14, 2024. This list-only historical record is sourced from the official FDA application da... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-45.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/june (June 2024) - 2024-08-15 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on August 15, 2024. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-43.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-08-22 — FDA Approval — FDA approved application. FDA recorded approval of BEYFORTUS on August 22, 2024. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761328 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/beyfortus-bla-761328-suppl-5.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/august (August 2024) - 2024-09-17 — FDA Approval — FDA approved application. FDA recorded approval of FASENRA on September 17, 2024. This list-only historical record is sourced from the official FDA applicati... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761070 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/fasenra-bla-761070-suppl-21.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2024-09-25 — FDA Approval — FDA approved application. FDA recorded approval of TAGRISSO on September 25, 2024. This list-only historical record is sourced from the official FDA applicat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/tagrisso-nda-208065-suppl-33.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024) - 2024-10-11 — FDA Approval — FDA approved application. FDA recorded approval of KOMBIGLYZE XR on October 11, 2024. This list-only historical record is sourced from the official FDA appli... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=200678 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/kombiglyze-xr-nda-200678-suppl-28.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/october (October 2024) - 2024-10-11 — FDA Approval — FDA approved application. FDA recorded approval of ONGLYZA on October 11, 2024. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=22350 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/onglyza-nda-022350-suppl-26.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/october (October 2024) - 2024-12-04 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on December 4, 2024. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-49.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024) - 2024-12-20 — FDA Approval — FDA approved application. FDA recorded approval of XIGDUO XR on December 20, 2024. This list-only historical record is sourced from the official FDA applicat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205649 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/xigduo-xr-nda-205649-suppl-23.md Month page: https://biopharmsignal.com/pdufa-calendar/2024/december (December 2024) - 2025-01-16 — FDA Approval — FDA approved application. FDA recorded approval of CALQUENCE on January 16, 2025. This list-only historical record is sourced from the official FDA applicati... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210259 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/calquence-nda-210259-suppl-11.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/january (January 2025) - 2025-01-17 — FDA Approval — FDA approved application. FDA recorded approval of DATROWAY on January 17, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761394 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/datroway-bla-761394-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/january (January 2025) - 2025-01-27 — FDA Approval — FDA approved application. FDA recorded approval of ENHERTU on January 27, 2025. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-bla-761139-suppl-32.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/january (January 2025) - 2025-02-28 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on February 28, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-51.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/february (February 2025) - 2025-03-28 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on March 28, 2025. This list-only historical record is sourced from the official FDA application d... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-50.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/march (March 2025) - 2025-06-23 — FDA Approval — FDA approved application. FDA recorded approval of DATROWAY on June 23, 2025. This list-only historical record is sourced from the official FDA application d... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761464 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/datroway-bla-761464-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/june (June 2025) - 2025-09-10 — FDA Approval — FDA approved application. FDA recorded approval of KOSELUGO on September 10, 2025. This list-only historical record is sourced from the official FDA applicat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213756 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/koselugo-nda-213756-suppl-5.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/september (September 2025) - 2025-09-15 — FDA Approval — FDA approved application. FDA recorded approval of AIRSUPRA on September 15, 2025. This list-only historical record is sourced from the official FDA applicat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214070 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/airsupra-nda-214070-suppl-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/september (September 2025) - 2025-10-17 — FDA Approval — FDA approved application. FDA recorded approval of TEZSPIRE on October 17, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761224 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/tezspire-bla-761224-suppl-6.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025) - 2025-10-20 — FDA Approval — FDA approved application. FDA recorded approval of BEYFORTUS on October 20, 2025. This list-only historical record is sourced from the official FDA applicati... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761328 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/beyfortus-bla-761328-suppl-12.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/october (October 2025) - 2025-11-19 — FDA Approval — FDA approved application. FDA recorded approval of KOSELUGO on November 19, 2025. This list-only historical record is sourced from the official FDA applicati... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213756 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/koselugo-nda-213756-suppl-6.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/november (November 2025) - 2025-11-25 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on November 25, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-52.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/november (November 2025) - 2025-12-15 — FDA Approval — FDA approved application. FDA recorded approval of ENHERTU on December 15, 2025. This list-only historical record is sourced from the official FDA applicatio... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-bla-761139-suppl-38.md Month page: https://biopharmsignal.com/pdufa-calendar/2025/december (December 2025) - 2026-02-19 — FDA Approval — FDA approved application. FDA recorded approval of CALQUENCE on February 19, 2026. This list-only historical record is sourced from the official FDA applicat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210259 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/calquence-nda-210259-suppl-12.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/february (February 2026) - 2026-04-15 — FDA Approval — FDA approved application. FDA recorded approval of WAINUA (AUTOINJECTOR) / WAINUA on April 15, 2026. This list-only historical record is sourced from the off... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217388 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/wainua-autoinjector-wainua-nda-217388-suppl-5.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-04-24 — FDA Approval — FDA approved application. FDA recorded approval of SAPHNELO on April 24, 2026. This list-only historical record is sourced from the official FDA application... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761451 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/saphnelo-bla-761451-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-04-27 — FDA Approval — FDA approved application. FDA recorded approval of BREZTRI AEROSPHERE on April 27, 2026. This list-only historical record is sourced from the official FDA ap... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212122 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/breztri-aerosphere-nda-212122-suppl-9.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-04-27 — FDA Approval — FDA approved application. FDA recorded approval of ENHERTU on April 27, 2026. This list-only historical record is sourced from the official FDA application d... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-bla-761139-suppl-39.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-04-27 — FDA Approval — FDA approved application. FDA recorded approval of SYMBICORT AEROSPHERE on April 27, 2026. This list-only historical record is sourced from the official FDA... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216579 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/symbicort-aerosphere-nda-216579-suppl-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026) - 2026-05-13 — FDA Approval — FDA approved application. FDA recorded approval of FASENRA on May 13, 2026. This list-only historical record is sourced from the official FDA application dat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761070 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/fasenra-bla-761070-suppl-23.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/may (May 2026) - 2026-05-15 — FDA Approval — FDA approved application. FDA recorded approval of BAXFENDY on May 15, 2026. This list-only historical record is sourced from the official FDA application da... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219878 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/baxfendy-nda-219878-orig-1.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/may (May 2026) - 2026-05-15 — FDA Approval — FDA approved application. FDA recorded approval of ENHERTU on May 15, 2026. This list-only historical record is sourced from the official FDA application dat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-bla-761139-suppl-43.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/may (May 2026) - 2026-05-22 — FDA Approval — FDA approved application. FDA recorded approval of DATROWAY on May 22, 2026. This list-only historical record is sourced from the official FDA application da... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761394 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/datroway-bla-761394-suppl-3.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/may (May 2026) - 2026-05-28 — FDA Approval — FDA approved application. FDA recorded approval of IMFINZI on May 28, 2026. This list-only historical record is sourced from the official FDA application dat... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761069 Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/imfinzi-bla-761069-suppl-53.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/may (May 2026) - 2026-06-02 — PDUFA — FDA approved DATROWAY for first-line metastatic TNBC. FDA approved DATROWAY for adults with unresectable or metastatic triple-negative breast cancer who are... Company: AstraZeneca PLC Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/datroway-first-line-metastatic-triple-negative-breast-cancer.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/june (June 2026) - 2026-06-15 — PDUFA — FDA approved BAXFENDY. FDA approved the first aldosterone synthase inhibitor for use with other antihypertensive drugs in adults whose hypertension is not ad... Company: AstraZeneca PLC Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219878Orig1s000ltr.pdf Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/baxfendy-baxdrostat-inadequately-controlled-hypertension.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/june (June 2026) - 2026-07-07 — PDUFA — FDA approved ENHERTU for post-neoadjuvant treatment. FDA approved ENHERTU as adjuvant treatment for adults with HER2-positive early breast cancer who have re... Company: AstraZeneca PLC Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage Event detail: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-post-neoadjuvant-her2-positive-early-breast-cancer.md Month page: https://biopharmsignal.com/pdufa-calendar/2026/july (July 2026) ## Related Pages - Company page: https://biopharmsignal.com/company/AZN - Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar ## FAQ ### What does the AZN PDUFA calendar show? It shows active PDUFA and FDA decision milestones associated with AZN, including decision dates, application stage, and summary details when available. ### Where can I find more context for AZN? Use the BioPharmSignal company page for AZN 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.