FDA PDUFA Calendar 2026: Drug Approval Dates & Deadlines
Track 2026 FDA PDUFA dates for NDA, BLA, ANDA, and IND decisions. Free drug approval tracker with source-linked deadlines, calendar views, and daily updates.
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 27 NDAs and 23 BLAs.
| Sponsor | Product | Type | Application | PDUFA date | Status | Expand and copy |
|---|---|---|---|---|---|---|
| Sanofi | Dupixent | BLA | PENDING-provisional|sanofi|dupixent|chronicspontaneousur | decided | ||
| Merck | doravirine/islatravir | NDA | PENDING-provisional|merck|doravirineislatravir|hiv1infec | decided | ||
| Sanofi | Tzield | BLA | PENDING-provisional|sanofi|tzield|delayofonsetofstage3ty | decided | ||
| Axsome Therapeutics | AXS-05 | NDA | PENDING-provisional|axsometherapeutics|axs05|agitationas | decided | ||
| argenx | VYVGART | BLA | PENDING-provisional|argenx|vyvgart|achrabseronegativegen | decided | ||
| Daiichi Sankyo and AstraZeneca | ENHERTU followed by THP | BLA | PENDING-provisional|daiichisankyoandastrazeneca|enhertuf | decided | ||
| MannKind | Afrezza | BLA | PENDING-provisional|mannkind|afrezza|diabetesinchildrena | decided | ||
| Cingulate | CTx-1301 | NDA | PENDING-provisional|cingulate|ctx1301|attentiondeficithy | overdue | ||
| Daiichi Sankyo and AstraZeneca | DATROWAY | BLA | PENDING-provisional|daiichisankyoandastrazeneca|datroway | overdue | ||
| Arvinas | vepdegestrant | NDA | PENDING-provisional|arvinas|vepdegestrant|esr1mutatederp | decided | ||
| GSK and Spero Therapeutics | tebipenem HBr | NDA | PENDING-provisional|gskandsperotherapeutics|tebipenemhbr | overdue | ||
| Merck | KEYTRUDA + WELIREG | BLA | PENDING-provisional|merck|keytrudawelireg|adjuvanttreatm | overdue | ||
| Achieve Life Sciences | cytisinicline | NDA | PENDING-provisional|achievelifesciences|cytisinicline|ni | overdue | ||
| Arcutis Biotherapeutics | ZORYVE cream 0.3% | NDA | PENDING-provisional|arcutisbiotherapeutics|zoryvecream03 | overdue | ||
| Lantheus | LNTH-2501 (Ga 68 edotreotide) | NDA | PENDING-provisional|lantheus|lnth2501ga68edotreotide|pet | overdue | ||
| Unicycive Therapeutics | oxylanthanum carbonate | NDA | PENDING-provisional|unicycivetherapeutics|oxylanthanumca | overdue | ||
| Ionis Pharmaceuticals | olezarsen | NDA | PENDING-provisional|ionispharmaceuticals|olezarsen|sever | overdue | ||
| Viridian Therapeutics | veligrotug | BLA | PENDING-provisional|viridiantherapeutics|veligrotug|thyr | overdue | ||
| Ascelia Pharma | Orviglance | NDA | PENDING-provisional|asceliapharma|orviglance|liverimagin | overdue | ||
| Orca Bio | Orca-T | BLA | PENDING-provisional|orcabio|orcat|hematologicmalignancie | overdue | ||
| Vera Therapeutics | atacicept | BLA | PENDING-provisional|veratherapeutics|atacicept|iganephro | overdue | ||
| Daiichi Sankyo and AstraZeneca | ENHERTU | BLA | PENDING-provisional|daiichisankyoandastrazeneca|enhertu| | overdue | ||
| Corcept Therapeutics | relacorilant + nab-paclitaxel | NDA | PENDING-provisional|corcepttherapeutics|relacorilantnabp | upcoming | ||
| Celcuity | gedatolisib | NDA | PENDING-provisional|celcuity|gedatolisib|hrpositiveher2n | upcoming | ||
| Elevar Therapeutics | rivoceranib + camrelizumab | NDA | PENDING-provisional|elevartherapeutics|rivoceranibcamrel | upcoming | ||
| Sanofi | Sarclisa SC | BLA | PENDING-provisional|sanofi|sarclisasc|multiplemyeloma|20 | upcoming | ||
| Otsuka Pharmaceutical | centanafadine | NDA | PENDING-provisional|otsukapharmaceutical|centanafadine|a | upcoming | ||
| MannKind | FUROSCIX ReadyFlow Autoinjector | NDA | PENDING-provisional|mannkind|furoscixreadyflowautoinject | upcoming | ||
| Outlook Therapeutics, Inc. | ONS-5010 (bevacizumab-vikg) / LYTENAVA | BLA | PENDING-provisional|outlooktherapeuticsinc|ons5010bevaci | upcoming | ||
| Viatris | low-dose estrogen weekly patch | NDA | PENDING-provisional|viatris|lowdoseestrogenweeklypatch|c | upcoming | ||
| Replimune Group | RP1 (vusolimogene oderparepvec) | BLA | PENDING-provisional|replimunegroup|rp1vusolimogeneoderpa | upcoming | ||
| Moderna | mRNA-1010 | BLA | PENDING-provisional|moderna|mrna1010|seasonalinfluenzapr | upcoming | ||
| Lantheus | MK-6240 | NDA | PENDING-provisional|lantheus|mk6240|petimagingagenttarge | upcoming | ||
| Bristol Myers Squibb | iberdomide + daratumumab/dexamethasone | NDA | PENDING-provisional|bristolmyerssquibb|iberdomidedaratum | upcoming | ||
| Merck, Astellas, and Pfizer | KEYTRUDA + PADCEV | BLA | PENDING-provisional|merckastellasandpfizer|keytrudapadce | upcoming | ||
| Capricor Therapeutics | deramiocel | BLA | PENDING-provisional|capricortherapeutics|deramiocel|duch | upcoming | ||
| Ultragenyx Pharmaceutical | DTX401 | BLA | PENDING-provisional|ultragenyxpharmaceutical|dtx401|glyc | upcoming | ||
| Eisai and Biogen | LEQEMBI IQLIK | BLA | PENDING-provisional|eisaiandbiogen|leqembiiqlik|subcutan | upcoming | ||
| Jazz Pharmaceuticals | Ziihera | BLA | PENDING-provisional|jazzpharmaceuticals|ziihera|firstlin | upcoming | ||
| Gilead Sciences | bictegravir/lenacapavir | NDA | PENDING-provisional|gileadsciences|bictegravirlenacapavi | upcoming | ||
| ITM Isotope Technologies Munich | 177Lu-edotreotide | NDA | PENDING-provisional|itmisotopetechnologiesmunich|177lued | upcoming | ||
| PharmaEssentia | BESREMi | BLA | PENDING-provisional|pharmaessentia|besremi|essentialthro | upcoming | ||
| Advicenne | Sibnayal | NDA | PENDING-provisional|advicenne|sibnayal|distalrenaltubula | upcoming | ||
| Telix Pharmaceuticals | TLX101-Px (Pixclara) | NDA | PENDING-provisional|telixpharmaceuticals|tlx101pxpixclar | upcoming | ||
| Nuvalent | zidesamtinib | NDA | PENDING-provisional|nuvalent|zidesamtinib|ros1positiveno | upcoming | ||
| Ultragenyx Pharmaceutical | UX111 | BLA | PENDING-provisional|ultragenyxpharmaceutical|ux111|sanfi | upcoming | ||
| Merck | WINREVAIR | BLA | PENDING-provisional|merck|winrevair|pulmonaryarterialhyp | upcoming | ||
| Ionis Pharmaceuticals | zilganersen | NDA | PENDING-provisional|ionispharmaceuticals|zilganersen|ale | upcoming | ||
| Incyte Corporation / Mirum Pharmaceuticals | Zilurgisertib | NDA | PENDING-provisional|incytecorporationmirumpharmaceutical | upcoming | ||
| Praxis Precision Medicines | relutrigine | NDA | PENDING-provisional|praxisprecisionmedicines|relutrigine | upcoming |
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.
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.
Filter by application type to focus on NDA, BLA, ANDA, or IND records.
Switch to the timeline view to compare published target dates and observed decisions.
Use the table view when you need a compact source-linked working list.
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.