2026 FDA PDUFA dates
Published PDUFA target action dates for NDAs, BLAs, ANDAs, and INDs scheduled in 2026, sourced from FDA primary records and updated daily.
Tracking 50 published FDA PDUFA decisions, including 28 NDAs and 22 BLAs.
| Sponsor | Product | Type | Application | PDUFA date | Status | Expand and copy |
|---|---|---|---|---|---|---|
| REGENERON PHARMACEUTICALS | DUPIXENT | BLA | BLA 761055 SUPPL-74 | decided | ||
| MSD | IDVYNSO | NDA | NDA 216964 ORIG-1 | decided | ||
| PROVENTION BIO INC | TZIELD | BLA | BLA 761183 SUPPL-13 | decided | ||
| Axsome Therapeutics | AXS-05 | NDA | PENDING-provisional|axsometherapeutics|axs05|agitationas | decided | ||
| ARGENX BV | VYVGART | BLA | BLA 761195 SUPPL-16 | decided | ||
| Daiichi Sankyo and AstraZeneca | ENHERTU followed by THP | BLA | PENDING-provisional|daiichisankyoandastrazeneca|enhertuf | decided | ||
| MANNKIND | AFREZZA | BLA | BLA 022472 SUPPL-29 | decided | ||
| Cingulate | CTx-1301 | NDA | PENDING-provisional|cingulate|ctx1301|attentiondeficithy | decided | ||
| DAIICHI SANKYO INC | DATROWAY | BLA | BLA 761394 SUPPL-3 | decided | ||
| RIGEL PHARMS | VEPPANU | NDA | NDA 219835 ORIG-1 | decided | ||
| GLAXOSMITHKLINE | UTEBZI | NDA | NDA 215960 ORIG-1 | decided | ||
| Merck | KEYTRUDA + WELIREG | BLA | PENDING-provisional|merck|keytrudawelireg|adjuvanttreatm | decided | ||
| Achieve Life Sciences | cytisinicline | NDA | PENDING-provisional|achievelifesciences|cytisinicline|ni | decided | ||
| ARCUTIS | ZORYVE | NDA | NDA 215985 SUPPL-15 | decided | ||
| Lantheus | LNTH-2501 (Ga 68 edotreotide) | NDA | PENDING-provisional|lantheus|lnth2501ga68edotreotide|pet | decided | ||
| Unicycive Therapeutics | oxylanthanum carbonate | NDA | PENDING-provisional|unicycivetherapeutics|oxylanthanumca | decided | ||
| VIRIDIAN THERAPEUTICS INC | LUMVOA | BLA | BLA 761530 ORIG-1 | decided | ||
| IONIS PHARMS INC | TRYNGOLZA (AUTOINJECTOR) | NDA | NDA 218614 SUPPL-4 | decided | ||
| Ascelia Pharma | Orviglance | NDA | PENDING-provisional|asceliapharma|orviglance|liverimagin | decided | ||
| Orca Bio | Orca-T | BLA | PENDING-provisional|orcabio|orcat|hematologicmalignancie | decided | ||
| VERA THERAPEUTICS INC. | TRUTAKNA | BLA | BLA 761486 ORIG-1 | decided | ||
| Daiichi Sankyo and AstraZeneca | ENHERTU | BLA | PENDING-provisional|daiichisankyoandastrazeneca|enhertu| | decided | ||
| CORCEPT THERAP | LIFYORLI (COPACKAGED) | NDA | NDA 220641 ORIG-1 | decided | ||
| CELCUITY | REVTORPYK | NDA | NDA 219908 ORIG-1 | decided | ||
| SANOFI-AVENTIS U.S. LLC | SARCLISA ESCENA | BLA | BLA 761445 ORIG-1 | decided | ||
| Elevar Therapeutics | rivoceranib + camrelizumab | NDA | PENDING-provisional|elevartherapeutics|rivoceranibcamrel | decided | ||
| OTSUKA PHARMACEUTICAL CO LTD | SYMTRIYO | NDA | NDA 218145 ORIG-1 | decided | ||
| MannKind | FUROSCIX ReadyFlow Autoinjector | NDA | PENDING-provisional|mannkind|furoscixreadyflowautoinject | decided | ||
| OUTLOOK THERAPEUTICS, INC. | LYTENAVA | BLA | BLA 761320 ORIG-1 | decided | ||
| VIATRIS SPECIALTY | GWYN LO | NDA | NDA 219990 ORIG-1 | decided | ||
| Replimune Group | RP1 (vusolimogene oderparepvec) | BLA | PENDING-provisional|replimunegroup|rp1vusolimogeneoderpa | decided | ||
| Moderna | mRNA-1010 | BLA | PENDING-provisional|moderna|mrna1010|seasonalinfluenzapr | decided | ||
| CERVEAU LANTHEUS | TAUKLARIFY | NDA | NDA 220496 ORIG-1 | decided | ||
| BRISTOL MYERS SQUIBB | ZENBEXUS | NDA | NDA 221075 ORIG-1 | decided | ||
| Merck, Astellas, and Pfizer | KEYTRUDA + PADCEV | BLA | PENDING-provisional|merckastellasandpfizer|keytrudapadce | decided | ||
| Ultragenyx Pharmaceutical | DTX401 | BLA | PENDING-provisional|ultragenyxpharmaceutical|dtx401|glyc | decided | ||
| EISAI INC | LEQEMBI IQLIK | BLA | BLA 761375 SUPPL-1 | decided | ||
| JAZZ PHARMS | ZIIHERA | BLA | BLA 761416 SUPPL-2 | decided | ||
| GILEAD SCIENCES INC | BIXLENVO | NDA | NDA 221104 ORIG-1 | decided | ||
| ITM Isotope Technologies Munich | 177Lu-edotreotide | NDA | PENDING-provisional|itmisotopetechnologiesmunich|177lued | decided | ||
| PHARMAESSENTIA CORP | BESREMI | BLA | BLA 761166 SUPPL-13 | decided | ||
| Advicenne | Sibnayal | NDA | PENDING-provisional|advicenne|sibnayal|distalrenaltubula | decided | ||
| TELIX PHARMACEUTICALS US INC | PIXCLARA | NDA | NDA 218592 ORIG-1 | decided | ||
| NUVALENT INC | JIDEYTRO | NDA | NDA 220185 ORIG-1 | decided | ||
| Ultragenyx Pharmaceutical | UX111 | BLA | PENDING-provisional|ultragenyxpharmaceutical|ux111|sanfi | decided | ||
| Merck | WINREVAIR | BLA | BLA 761363 SUPPL-12 | decided | ||
| IONIS PHARMS INC | ZANVASTRO | NDA | NDA 220210 ORIG-1 | decided | ||
| Incyte Corporation / Mirum Pharmaceuticals | Zilurgisertib | NDA | NDA 221198 ORIG-1 | decided | ||
| Elevar Therapeutics | lirafugratinib | NDA | NDA 220425 ORIG-1 | decided | ||
| BIOFRONTERA | AMELUZ | NDA | NDA 208081 SUPPL-40 | decided |
Select any row to expand its full record. Use the calendar, timeline, status board, or table views above to filter, sort, and inspect source-linked details.
FDA PDUFA Calendar 2026: Drug Approval Dates & Deadlines
Track 2026 FDA review dates and approval decisions. Browse products, sponsors, application types, source-linked deadlines, and outcomes in the PDUFA calendar.
How to use the 2026 PDUFA calendar
Use this year-specific view to monitor FDA target action dates, compare review timing across sponsors and application types, and prepare portfolio reviews around the milestones that matter most.
2026 PDUFA calendar FAQ
What is the 2026 FDA PDUFA calendar?
The 2026 FDA PDUFA calendar tracks public target action dates and review milestones for drug and biologics applications where Assyro has source-linked records.
Which applications are included?
The calendar focuses on publicly available NDA and BLA review milestones and separates records with published target dates from records that do not yet have a public date.
How often is the PDUFA calendar updated?
Assyro refreshes the calendar from public FDA source data and shows the latest sync timestamp inside the tool when available.