Regulatory Tools — FDA Catalyst Tracker
PDUFA Calendar 2026
Reference hub of publicly disclosed FDA action dates for upcoming NDA, BLA, and supplemental reviews. Filter by month, verify every date against sponsor SEC 8-K filings, and use our calculator to estimate clocks for undisclosed programs.
Quick Answer
The PDUFA calendar lists publicly disclosed FDA action dates for upcoming NDA, BLA, and supplemental reviews — the regulatory deadlines investors and business development teams track as approval catalysts. Filter by month, verify each date against sponsor SEC 8-K filings, and cross-link to our PDUFA date calculator for undisclosed programs. Free, no login — built for pharma professionals, not paywalled catalyst trackers.
2026 PDUFA Snapshot
Entries tracked
15 publicly disclosed targets
Date span
June — December 2026 (sample set)
Primary sources
SEC 8-K · IR press releases · FDA acceptance notices
Upcoming FDA Action Dates
Filter the table by month. Dates reflect sponsor-disclosed PDUFA targets as of mid-2026 — confirm before investment or regulatory planning.
Showing 15 of 15 entries
| PDUFA date | Company | Drug / product | Review type | Notes |
|---|---|---|---|---|
| Arcutis Biotherapeutics | ZORYVE (roflumilast) cream 0.3% | sNDA · Standard | Pediatric plaque psoriasis expansion to ages 2–5; PDUFA disclosed Nov 2025. | |
| Lantheus | LNTH-2501 (Ga 68 edotreotide) | NDA · Standard | PET imaging for SSTR+ neuroendocrine tumors; review extended for CMC (not efficacy). | |
| Unicycive Therapeutics | Oxylanthanum carbonate (OLC) | NDA resub · Class II | Hyperphosphatemia in CKD patients on dialysis; Class II resubmission accepted Jan 2026. | |
| Ionis Pharmaceuticals | Olezarsen | sNDA · Priority | Severe hypertriglyceridemia (sHTG); priority review accepted Feb 2026. | |
| Viridian Therapeutics | Veligrotug | BLA · Priority | Thyroid eye disease (TED); breakthrough and priority review designations. | |
| Orca Bio | Orca-T | BLA · Priority | Hematologic malignancies; PDUFA extended after CMC major amendment (no new clinical data). | |
| Daiichi Sankyo / AstraZeneca | ENHERTU (fam-trastuzumab deruxtecan-nxki) | sBLA · Priority | Post-neoadjuvant HER2+ early breast cancer with residual invasive disease (DESTINY-Breast05). | |
| Vera Therapeutics | Atacicept | BLA · Priority | IgA nephropathy (IgAN); accelerated approval pathway under priority review. | |
| Sanofi | Sarclisa SC (isatuximab-irfc) | BLA · Standard | Subcutaneous/on-body injector for multiple myeloma; review extended for CMC review. | |
| Elevar Therapeutics | Rivoceranib + camrelizumab | NDA resub · Integrated | First-line unresectable/metastatic HCC; integrated NDA+BLA review after prior CRL. | |
| Moderna | mRNA-1010 (mFlusiva) | BLA · Standard | Seasonal influenza vaccine ages 50+; VRBPAC voted 9–0 favorable Feb 2026. | |
| Astellas / Pfizer | PADCEV + KEYTRUDA (± QLEX) | sBLA · Priority | Perioperative muscle-invasive bladder cancer regardless of cisplatin eligibility (EV-304). | |
| Gilead Sciences | Bictegravir / lenacapavir (BIC/LEN) | NDA · Priority | Once-daily single-tablet HIV regimen for virologically suppressed adults. | |
| Scholar Rock | Apitegromab | BLA resub · Class II | Spinal muscular atrophy (SMA); resubmission includes two fill-finish manufacturing sites. | |
| Gilead / Kite | Anito-cel (anitocabtagene autoleucel) | BLA · Priority | Fourth-line relapsed/refractory multiple myeloma; BCMA-directed CAR T (iMMagine-1). |
Verify via SEC 8-K: PDUFA dates change when sponsors file major amendments, receive CRLs, or disclose extensions. Search EDGAR for the company ticker + “PDUFA” or “target action date” before relying on any calendar entry for trading or launch planning.
What Is a PDUFA Date?
Under PDUFA, FDA commits to review-performance goals in exchange for user fees paid by drug and biologic sponsors. The PDUFA date — also called the target action date or goal date — is when FDA aims to complete its review of an NDA, BLA, or supplemental application and communicate a regulatory decision.
Standard original applications are generally reviewed within 10 months of filing (about 12 months from receipt after the 60-day filing review). Priority review compresses that clock to 6 months from filing. Resubmissions after a CRL follow shorter Class 1 (2-month) or Class 2 (6-month) clocks.
How Investors Use a PDUFA Calendar
PDUFA vs AdCom vs CRL
PDUFA date
FDA review goal deadline under user-fee commitments. Outcome may be approval, CRL, or extension.
AdCom meeting
Optional FDA advisory panel reviewing benefit-risk. Often scheduled 1–2 months before PDUFA; vote is advisory, not binding.
Complete Response Letter
Deficiency letter deferring approval. Sponsor must address CMC, clinical, or labeling issues and resubmit to restart a shorter review clock.
How to Verify PDUFA Dates
- Search SEC EDGAR for the sponsor’s latest Form 8-K mentioning “PDUFA,” “Prescription Drug User Fee Act,” or “target action date.”
- Read the acceptance or priority-review press release — the PDUFA date is usually stated in the first paragraph.
- Check subsequent 8-K filings for extensions tied to major amendments, AdCom scheduling, or manufacturing inspections.
- Reconcile with FDA’s publicly searchable approval database after the decision; goal dates are not listed pre-decision.
- Use our PDUFA Date Calculator only for estimating undisclosed clocks from receipt or filing dates.
PDUFA Glossary
- PDUFA
- Prescription Drug User Fee Act — statute authorizing FDA user fees and review performance goals.
- NDA
- New Drug Application for small-molecule and certain other drug products.
- BLA
- Biologics License Application for vaccines, cell therapies, and other biologics.
- sNDA / sBLA
- Supplemental application seeking a new indication, formulation, or labeling change for an approved product.
- CRL
- Complete Response Letter — FDA communication deferring approval until identified deficiencies are resolved.
- AdCom
- Advisory Committee — independent expert panel that advises FDA; common for novel modalities and contested benefit-risk profiles.
- Priority Review
- Expedited 6-month review goal (from filing) for therapies with potential to improve treatment of serious conditions.
- Major Amendment
- Substantial new CMC or clinical information submitted during review; can extend the PDUFA goal date by up to 3 months.
Evidence & sources
- FDA: PDUFA VII Reauthorization Performance Goals and Procedures (FY 2023–2027)
- FDA: Prescription Drug User Fee Amendments (PDUFA overview)
- SEC EDGAR — verify PDUFA dates in sponsor Form 8-K filings
- Competitive landscape: BiopharmaWatch PDUFA Calendar aggregates daily-updated catalyst tables with proprietary probability-of-approval scores for investor trading — not source-verification education. pdufa.bio layers run-up history and cohort base rates on disclosed dates but does not walk users through SEC 8-K verification or link to a PDUFA clock estimator. NovaPharmaNews provides a free reference sample with month filtering, explicit verify-via-8-K guidance, regulatory glossary, and cross-links to our PDUFA Date Calculator — no paywall or approval-probability scores.