# August 2026 PDUFA Calendar: FDA Decision Dates & Biotech Catalysts Canonical URL: https://biopharmsignal.com/pdufa-calendar/2026/august BioPharmSignal tracks active PDUFA and FDA decision milestones for August 2026. ## PDUFA Events In August 2026 - 2026-08-02 — REPL — Replimune Group Stage: PDUFA Summary: FDA granted accelerated approval to TUDRIQEV plus nivolumab. FDA granted accelerated approval for TUDRIQEV in combination with nivolumab for adults with unre... Source: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm Event detail: https://biopharmsignal.com/pdufa-calendar/REPL/rp1-nivolumab-advanced-melanoma-review-3.md Company page: https://biopharmsignal.com/company/REPL - 2026-08-05 — MRNA — Moderna, Inc. Stage: PDUFA Summary: FDA approved mFLUSIVA for adults aged 50 and older. FDA granted traditional approval for adults aged 50–64 and accelerated approval for adults aged 65 and ol... Source: https://investors.modernatx.com/news/news-details/2026/Moderna-Receives-U-S--FDA-Approval-for-Influenza-Vaccine-mFLUSIVA/default.aspx Event detail: https://biopharmsignal.com/pdufa-calendar/MRNA/mrna-1010-influenza.md Company page: https://biopharmsignal.com/company/MRNA - 2026-08-13 — LNTH — Lantheus Holdings, Inc. Stage: PDUFA Summary: FDA approved TAUKLARIFY for tau PET imaging. FDA approved TAUKLARIFY (florquinitau F 18), previously known as MK-6240, for PET imaging of the brain in adults... Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220496 Event detail: https://biopharmsignal.com/pdufa-calendar/LNTH/mk-6240-alzheimers-disease.md Company page: https://biopharmsignal.com/company/LNTH - 2026-08-17 — BMY — BMYBristol-Myers Squibb Company Stage: PDUFA Summary: Original PDUFA date superseded by early approval.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... 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 Company page: https://biopharmsignal.com/company/BMY - 2026-08-17 — MRK — Merck Stage: PDUFA Summary: Original PDUFA date superseded by early approval. FDA had assigned August 17 as the target action date for the supplemental applications. The agency approved... 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 Company page: https://biopharmsignal.com/company/MRK - 2026-08-22 — CAPR — Capricor Therapeutics Stage: PDUFA Summary: FDA decision expected. PDUFA target action date for the Class 2 resubmission of the deramiocel BLA. Source: https://www.capricor.com/investors/news-events/press-releases/detail/338/capricor-therapeutics-announces-establishment-of-new-pdufa Event detail: https://biopharmsignal.com/pdufa-calendar/CAPR/deramiocel-duchenne-cardiomyopathy-review-2.md Company page: https://biopharmsignal.com/company/CAPR - 2026-08-23 — RARE — Ultragenyx Pharmaceutical Stage: PDUFA Summary: Original PDUFA date superseded by early approval. FDA had assigned August 23 as the PDUFA target action date for the DTX401 BLA. The agency granted accelerat... Source: https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-acceptance-and-priority-review Event detail: https://biopharmsignal.com/pdufa-calendar/RARE/dtx401-glycogen-storage-disease-type-ia.md Company page: https://biopharmsignal.com/company/RARE - 2026-08-24 — BIIB — Biogen Stage: PDUFA Summary: Original PDUFA date superseded by early approval. FDA had extended the PDUFA action date from May 24 to August 24 after determining that additional informati... Source: https://stagemedia-us.eisai.com/2026-05-08-Update-on-FDA-Priority-Review-of-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-as-a-Starting-Dose-for-Early-Alzheimers-Disease Event detail: https://biopharmsignal.com/pdufa-calendar/BIIB/leqembi-iqlik-subcutaneous-initiation-alzheimers-disease.md Company page: https://biopharmsignal.com/company/BIIB - 2026-08-25 — JAZZ — Jazz Pharmaceuticals Stage: PDUFA Summary: FDA approved two first-line ZIIHERA regimens. FDA approved ZIIHERA with fluoropyrimidine- and platinum-containing chemotherapy plus TEVIMBRA for adults with... Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction Event detail: https://biopharmsignal.com/pdufa-calendar/JAZZ/zanidatamab-combinations-her2-positive-gea.md Company page: https://biopharmsignal.com/company/JAZZ - 2026-08-26 — RVMD — Revolution Medicines Stage: PDUFA Summary: FDA approved RASONQUE for metastatic pancreatic adenocarcinoma. FDA approved once-daily oral RASONQUE for adults with metastatic pancreatic adenocarcinoma wh... Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma Event detail: https://biopharmsignal.com/pdufa-calendar/RVMD/daraxonrasib-metastatic-pancreatic-adenocarcinoma.md Company page: https://biopharmsignal.com/company/RVMD - 2026-08-27 — GILD — Gilead Sciences Stage: PDUFA Summary: FDA decision expected. PDUFA action date for the once-daily bictegravir and lenacapavir single-tablet regimen NDA. Source: https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir Event detail: https://biopharmsignal.com/pdufa-calendar/GILD/bictegravir-lenacapavir-hiv-1.md Company page: https://biopharmsignal.com/company/GILD - 2026-08-27 — ROIV — Roivant Stage: PDUFA Summary: FDA approved LISRAYA for adults with dermatomyositis. FDA approved once-daily oral LISRAYA 30 mg for the treatment of dermatomyositis in adults. FDA describe... Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults Event detail: https://biopharmsignal.com/pdufa-calendar/ROIV/brepocitinib-dermatomyositis.md Company page: https://biopharmsignal.com/company/ROIV - 2026-08-31 — PTGX — Protagonist Therapeutics Inc Stage: PDUFA Summary: FDA decision expected. Protagonist disclosed an August 2026 PDUFA goal month. The structured Event Date uses August 31 as the month-end representation of thi... Source: https://www.sec.gov/Archives/edgar/data/1377121/000110465926055629/tm2613550d1_ex99-1.htm Event detail: https://biopharmsignal.com/pdufa-calendar/PTGX/rusfertide-polycythemia-vera.md Company page: https://biopharmsignal.com/company/PTGX - 2026-08-31 — REGN — Regeneron Pharmaceuticals Stage: PDUFA Summary: FDA decision expected. Regeneron disclosed an August 2026 FDA target action month. The structured Event Date uses August 31 as the month-end representation o... Source: https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/ Event detail: https://biopharmsignal.com/pdufa-calendar/REGN/garetosmab-fibrodysplasia-ossificans-progressiva.md Company page: https://biopharmsignal.com/company/REGN ## How To Use This Page Use the event date, ticker, company, and stage to understand which regulatory decisions may matter during the month. Open the company page for recent news and stock context. ## FAQ ### What is listed on the August 2026 PDUFA calendar? This page lists active BioPharmSignal PDUFA and FDA decision milestones dated in August 2026, including ticker, company, application stage, and available source context. ### Can PDUFA dates change? Yes. FDA target action dates can move when applications, reviews, labels, or company guidance change. Use the page as a dated research aid and check source links when available. ### How is this different from LiveFeed? The PDUFA calendar is organized by expected FDA decision date. LiveFeed is organized by newly published biotech news and company updates.