FDA Calendar - PDUFA Dates & AdCom Meetings
47 PDUFA dates + 0 Advisory Committee meetings
FDA Advisory Committee Meetings
AdComNo upcoming drug AdCom meetings currently scheduled. FDA announces meetings via Federal Register notice typically 60–90 days in advance. AdCom votes often predict FDA approval decisions, so a favorable vote increases approval likelihood.
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the target date by which the FDA commits to making a decision on a drug application (NDA or BLA). These dates are set when the FDA accepts a drug application for review.
- Standard Review: 10 months from submission acceptance
- Priority Review: 6 months from submission acceptance
- Outcome: Approval, Complete Response Letter (CRL), or extension
Data Source: SEC 8-K Filings
PDUFA dates are extracted from company SEC 8-K filings where companies announce FDA acceptance of their drug applications. This provides authentic, primary-source data directly from regulatory filings.
Last updated: September 20, 2026
Upcoming PDUFA Dates by Month
September 2026
October 2026
November 2026
December 2026
January 2027
February 2027
April 2027
May 2027
Recent Decisions (Last 6 Months)
35 approved, 14 pending outcome
September 2026
sNDA accepted + Priority Review (May 19, 2026). IntraBio privately held.
Ultragenyx Form 8-K, Item 8.01, filed 2026-04-02: 'the U.S. Food and Drug Administration (the "FDA") has accepted for review the Company's resubmitted Biologics License Application seeking accelerated approval for UX111 (rebisufligene etisparvovec) AAV9 gene therapy as a treatment for patients with Sanfilippo syndrome Type A (MPS IIIA). The FDA set a Prescription Drug User Fee Act (PDUFA) action date of September 19, 2026.' Corroborated in Ultragenyx's Q1 2026 press release filed as 8-K EX-99.1 on 2026-05-05 (https://www.sec.gov/Archives/edgar/data/1515673/000119312526206368/rare-ex99_1.htm): 'In February 2025, the FDA granted the BLA Priority Review and, in April 2026, assigned a PDUFA action date of September 19, 2026.' The filing is a BLA RESUBMISSION seeking accelerated approval. No approval or CRL as of 2026-08-02 (no Ultragenyx 8-K filed after 2026-05-18). This entry is absent from both pdufa-manual.json and pdufa-calendar.json.
Advicenne official press release, Paris, January 19, 2026: 'The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026.' FDA accepted the New Drug Application for Sibnayal (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for distal renal tubular acidosis; NDA submitted November 2, 2025 and filed as a 505(b)(2) incorporating the European clinical studies. Sibnayal already holds marketing authorization in the EU and Great Britain for dRTA. No FDA designations are disclosed in the release, so none are asserted here. Advicenne is listed on Euronext Growth Paris (ALDVI, FR0013296746) and files no SEC reports. CAVEAT: Advicenne opened French safeguard proceedings on May 5, 2026 to restructure its financial liabilities; no change to the PDUFA date has been announced through 2026-08-02.
August 2026
sBLA accepted, Standard review, PDUFA Aug 30, 2026 (confirmed Jan 13, 2026).
NDA accepted (Nov 13, 2025), PDUFA Aug 28, 2026. COMPETE trial met PFS vs everolimus. ITM privately held (Germany).
ALREADY ACTIONED - add with outcome=approved, not as an upcoming catalyst. Biogen Q2 2026 10-Q (filed Jul 29, 2026): 'In May 2026 the FDA extended the review period by three months for the supplemental BLA for LEQEMBI subcutaneous autoinjector, LEQEMBI IQLIK, for a weekly initiation dose, with a new PDUFA action date of August 24, 2026; in July 2026 the FDA approved the supplemental BLA.' Approval is also cited in Biogen's Q2 2026 earnings release, 8-K Ex-99.1 filed Jul 29, 2026 ('LEQEMBI IQLIK ... approved by the FDA as an initiation dose'). Attribution caveat: the BLA is held by Eisai Co., Ltd.; Biogen is the 50/50 collaboration partner and is the SEC-filing source of the date.
[ADVISORY COMMITTEE 2026-07-29: FDA Cellular, Tissue and Gene Therapies Advisory Committee voted 3 for / 9 against / 0 abstain that available evidence did NOT support effectiveness for DMD cardiomyopathy. Source: Capricor 8-K 2026-07-30, accession 0001104659-26-088667, Item 8.01.]
Approved 2026-08-19 as PASATRU (ORIG BLA761508). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-28; 0d from the PDUFA date.
Approved 2026-08-13 as ZENBEXUS (ORIG NDA221075). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-28; 4d from the PDUFA date.
FDA Priority Review (Apr 20, 2026) for Keytruda + Padcev in cisplatin-ELIGIBLE perioperative MIBC (EV-304/KEYNOTE-B15). Distinct from the cisplatin-ineligible application.
Lantheus IR release (Oct 28, 2025): FDA accepted the NDA for MK-6240, an F 18-labeled tau-targeted PET imaging agent; PDUFA target action date August 13, 2026; Fast Track designation. Corroborated in Lantheus 8-K Ex-99.1 filed Nov 6, 2025 (https://www.sec.gov/Archives/edgar/data/1521036/000119312525268103/lnth-ex99_1.htm) and repeated in the FY2025 10-K and Q1 2026 10-Q. Supported by two pivotal Phase 3 trials that met sensitivity and specificity endpoints. This is the real drug behind the pdufa-calendar.json parse-error row 'Lantheus Holdings, Inc. / drugName: LNTH' at 2026-08-13.
Approved 2026-08-05 as ORZEYFUL (ORIG NDA220860). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-28; 5d from the PDUFA date.
Class 1 resubmission accepted Jun 26, 2026 (PDUFA Aug 2, 2026) after a CRL on the Apr-2026 cycle. AdCom expected late Jul 2026. Combination with nivolumab.
July 2026
APPROVED EARLY — FDA acted on 2026-05-27, about two months AHEAD of the 2026-07-30 target action date we had on file. That early action is why the automated window scan found "no FDA approval found in window" — the search window was anchored on the July date. Brand name: DECNUPAZ (pivekimab sunirine-pvzy). Approval date: 2026-05-27. Indication: adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare aggressive hematologic malignancy. It is a CD123-directed antibody-drug conjugate (antibody + alkylating agent conjugate) and is AbbVie's first ADC approved in a blood cancer; per AbbVie it is the first and only ADC for BPDCN that is initiated in an outpatient setting. Asset origin: ImmunoGen (IMGN632), acquired by AbbVie in Feb 2024. Basis: Phase 1/2 CADENZA trial. Prior designations: Breakthrough Therapy (Oct 2020, r/r BPDCN) and orphan drug; BLA submitted September 2025. Label carries a Boxed Warning for hepatotoxicity including hepatic veno-occlusive disease. Primary source verified by opening AbbVie's official newsroom press release (news.abbvie.com), dated 2026-05-27; the FDA oncology approval notice corroborates the same date and the -pvzy suffix but its page 404'd when fetched directly, so it is not cited as the primary. NO evidence of any second/separate pivekimab BLA with a 2026-07-30 action date — searches for one returned nothing; the AML combination program (pivekimab + venetoclax/azacitidine, REVIVAL) is still in Phase 2/3 and has no pending application. Recommended action: update data/pdufa-outcomes-manual.json to outcome=approved with outcomeDate 2026-05-27 and note that FDA acted ahead of the recorded goal date, and consider correcting the stored PDUFA target (2026-07-30 looks like an estimated goal date rather than a company-confirmed one — worth re-verifying against the BLA acceptance release before trusting it elsewhere). FDA acted 2026-05-27 (target was 2026-07-30). Source: https://news.abbvie.com/2026-05-27-U-S-FDA-Approves-DECNUPAZTM-pivekimab-sunirine-pvzy-for-Treatment-of-Adult-Patients-with-Blastic-Plasmacytoid-Dendritic-Cell-Neoplasm,-an-Ultra-Rare-and-Aggressive-Blood-Cancer-With-Limited-Treatment-Options
Approved 2026-07-24 as LYTENAVA (ORIG BLA761320). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-02; 5d from the PDUFA date.
NDA submitted Sep 26, 2025. PDUFA estimated at 10 months (standard review). D1/D5 partial agonist.
EXPLICIT company-stated CRL — not inferred from absence of approval. FDA acted 13 days EARLY, on 2026-07-10, ahead of the 2026-07-23 PDUFA target action date, which is why an approval-window scan found nothing. FDA acted 2026-07-10 (target was 2026-07-23). Source: https://elevartx.com/2026/07/10/elevar-crl-july-2/
Approved 2026-07-14 as REVTORPYK (ORIG NDA219908). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-02; 3d from the PDUFA date.
APPROVED EARLY — brand name Lifyorli (relacorilant), approved 2026-03-25, roughly 3.5 months AHEAD of the 2026-07-11 PDUFA target action date. That early action is exactly why the auto-matcher reported "no FDA approval found in window": it searched on/after the PDUFA date, but the FDA acted well before it. Approved indication: in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens, at least one containing bevacizumab. Lifyorli is described by the company as the first FDA-approved selective glucocorticoid receptor antagonist (SGRA). Basis: pivotal Phase 3 ROSELLA (n=381), which met dual primary endpoints — median OS 16.0 vs 11.9 months (HR 0.65, p=0.0004) and a 30% reduction in progression risk (HR 0.70, p=0.008, PFS-BICR). FDA acted 2026-03-25 (target was 2026-07-11). Source: https://www.sec.gov/Archives/edgar/data/1088856/000119312526123543/d123475d8k.htm
Approved 2026-07-07 as TRUTAKNA (ORIG BLA761486). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-02; 0d from the PDUFA date.
APPROVED — and approved EARLY, which is why the auto-matcher's window search missed it. The FDA acted roughly seven weeks ahead of the 2026-07-07 PDUFA target action date. FDA acted 2026-05-18 (target was 2026-07-07). Source: https://www.sec.gov/Archives/edgar/data/901832/000165495426005038/a6159e.htm
June 2026
TROPION-Breast02 Phase 3: 5.0-month improvement in median OS. Partner: Daiichi Sankyo.
Approved 2026-06-26 as LUMVOA (ORIG BLA761530). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 4d from the PDUFA date.
Approved 2026-06-24 as TRYNGOLZA (AUTOINJECTOR) (SUPPL NDA218614). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 6d from the PDUFA date.
CRL explicitly confirmed by the company's own IR newsroom release, dated June 26, 2026 (three days before the June 29, 2026 PDUFA date) — I opened the Lantheus IR page directly and it states the FDA issued a Complete Response Letter for the LNTH-2501 NDA. This is NOT an inference from absence of approval. FDA acted 2026-06-26 (target was 2026-06-29). Source: https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-complete-response-letter-fda-lnth-2501-ga-68
Approved 2026-06-29 as ZORYVE (SUPPL NDA215985). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 0d from the PDUFA date.
Approved 2026-06-05 as HYMPAVZI (SUPPL BLA761369). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 24d from the PDUFA date.
SECOND CRL for OLC, announced by company press release on 2026-06-30 at 7:05am EDT (one day after the 2026-06-29 PDUFA target action date). No approval, no brand name. FDA acted 2026-06-30 (target was 2026-06-29). Source: https://ir.unicycive.com/news/detail/123/unicycive-therapeutics-receives-complete-response-letter
CRL confirmed by explicit company statement. Press release "Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA", dateline "SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE)". Indication: nicotine dependence / smoking cessation in adults (NDA submitted June 2025, accepted Sept 2025, PDUFA 2026-06-20). Subheads: "CRL Cites Deficiencies at Third-Party Manufacturing Facility" and "No Efficacy or Clinical Safety Deficiencies Identified". FDA acted 2026-06-22 (target was 2026-06-20). Source: https://ir.achievelifesciences.com/news-events/press-releases/detail/264/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda
Approved 2026-06-24 as KEYTRUDA QLEX (SUPPL BLA761467). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 5d from the PDUFA date.
APPROVED — but note this sBLA is a CMC/manufacturing supplement, NOT a new indication. Brand name: ARCALYST (rilonacept), an IL-1 alpha/beta trap already approved for CAPS (2008), DIRA, and recurrent pericarditis (March 2021). No new indication or label expansion resulted from this action. Source: https://www.sec.gov/Archives/edgar/data/1730430/000110465926087545/knsa-20260630x10q.htm
EXPLICIT company-stated CRL — not inferred from absence of approval. FDA acted TWO WEEKS EARLY: the CRL was issued 2026-06-04, ahead of the 2026-06-18 PDUFA date, which is why an approval-window scan found nothing. Company announced it 2026-06-05 at 00:56 CEST (= evening of Jun 4 US time); the company's own 2026-06-26 regulatory update states "The FDA issued a CRL on June 4, 2026," so outcomeDateISO is set to 2026-06-04. FDA acted 2026-06-04 (target was 2026-06-18). Source: https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-receives-crl-from-u-s-fda-for-nilopki/
First-in-class aldosterone synthase inhibitor. BaxHTN Phase 3. PDUFA date estimated (Q2 2026 per company). Priority Review via voucher.
DELAYED — PDUFA extended before the 2026-06-15 action date; NOT approved and NOT a CRL. FDA acted 2026-05-27 (target was 2026-06-15). Source: https://www.sec.gov/Archives/edgar/data/901832/000165495426005381/a7798f.htm
CRL issued on the PDUFA date itself (2026-06-10), announced same day by Camurus AB in an official company press release titled "Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly". This is the SECOND manufacturing-related CRL for this NDA: the first was announced 2024-10-22 after a September 2024 cGMP inspection at a third-party manufacturer; the December 2025 resubmission carried the 2026-06-10 PDUFA date and was again turned down on the same facility grounds. Cause is explicitly CMC/facility, NOT clinical — the release states the CRL "does not relate to the clinical efficacy or safety of CAM2029"; FDA additionally recommended a labeling change to the oxygen absorber component of the packaging. CEO Fredrik Tiberg: "The CRL is disappointing. We are working toward resubmission of the NDA in the near term, while maintaining launch readiness and with no change to our 2026 financial outlook." Source: https://www.camurus.com/media/press-releases/2026/camurus-provides-regulatory-update-on-the-us-nda-for-cam2029-oclaiz-in-acromegaly/
Oral PROTAC ER degrader. Jointly developed by Arvinas and Pfizer. Based on Phase 3 VERITAC-2 trial (vs fulvestrant).
May 2026
CRL, explicitly stated by the company. Cingulate filed an 8-K dated 2026-06-02 (accession 0001493152-26-026760, Items 7.01/8.01/9.01) announcing the FDA issued a Complete Response Letter for the CTx-1301 (dexmethylphenidate HCl) NDA in ADHD — two days after the 2026-05-31 PDUFA target action date. The quoted evidence is from Item 8.01 of the 8-K body itself; the same language appears in the attached press release, Exhibit 99.1 (https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/ex99-1.htm), headlined "Cingulate Receives Complete Response Letter from FDA for CTx-1301 / No Clinical Safety or Efficacy Concerns Currently Identified / Agency Feedback Primarily Focused on CMC-Related Requests". CEO Shane J. Schaffer: "We are encouraged that the FDA's response was limited to specific information requests related to CMC and did not currently identify any issues related to the clinical safety or efficacy of CTx-1301... we have nearly $30 million in cash reserves, which we believe provides sufficient capital to address the issues raised and execute on the resubmission process and continue pre-commercial activities into 2027." FDA acted 2026-06-02 (target was 2026-05-31). Source: https://www.sec.gov/Archives/edgar/data/1862150/000149315226026760/form8-k.htm
Approved 2026-05-29 as AFREZZA (SUPPL BLA022472). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 0d from the PDUFA date.
Approved 2026-05-21 as LINZESS (SUPPL NDA202811). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 3d from the PDUFA date.
Approved 2026-05-15 as ENHERTU (SUPPL BLA761139). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 3d from the PDUFA date.
53% reduction in recurrence/death vs T-DM1. Partner: Daiichi Sankyo. APPROVED May 15, 2026, ~7 weeks ahead of the July 7 PDUFA target (FDA cleared both early-BC indications the same day).
Approved 2026-05-08 as VYVGART HYTRULO (SUPPL BLA761304). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 2d from the PDUFA date.
April 2026
APPROVED ON the PDUFA date, 2026-04-30. Brand name: AUVELITY (dextromethorphan HBr and bupropion HCl). New indication: agitation associated with dementia due to Alzheimer's disease — this was an sNDA adding a second indication to a brand first approved in Aug 2022 for major depressive disorder, which is exactly why the auto-matcher found "no FDA approval found in window": Drugs@FDA logs this as a supplement to the existing NDA, not a new drug approval, so any scan of new-approval records will keep missing it. Recommend matching sNDA outcomes on application-supplement records or manual PDUFA outcome entry rather than the new-approval feed. Source: https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/axsm-20260430.htm
Approved 2026-04-20 as IDVYNSO (ORIG NDA216964). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 8d from the PDUFA date.
CRL confirmed on the PDUFA date itself. This was Replimune's SECOND CRL for RP1 (the first was July 2025); the 2026-04-10 action date came from the Class 2 BLA resubmission the FDA accepted in October 2025. Verified from SEC EDGAR (CIK 0001737953): 8-K accession 0001104659-26-042141, event date 2026-04-10, filed 2026-04-13, carrying both Item 7.01 and Item 8.01 disclosure plus the April 10, 2026 press release as Exhibit 99.1 (https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_ex99-1.htm). CEO Sushil Patel disputed the decision and announced job cuts, saying "without timely accelerated approval, the development of RP1 will not be viable." No approval, no brand name. Source: https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_8k.htm
Approved March 30, 2026 for spinal muscular atrophy. Based on DEVOTE study. Source: https://investors.biogen.com/news-releases/news-release-details/fda-approves-new-high-dose-regimen-spinrazar-nusinersen-spinal
March 2026
Approved March 26, 2026. Accelerated approval for pediatric severe LAD-I. Priority Review Voucher granted. Source: https://www.businesswire.com/news/home/20260326279809/en/Rocket-Pharmaceuticals-Announces-FDA-Approval-of-KRESLADI-for-Pediatric-Patients-with-Severe-Leukocyte-Adhesion-Deficiency-I-LAD-I
Approved March 19, 2026 for acquired hypothalamic obesity (adults and pediatric ages 4+). PDUFA had been extended 3 months from original date. Based on Phase 3 TRANSCEND trial (-18.4% placebo-adjusted BMI reduction). Source: https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer-1/
Frequently asked
Common questions about PDUFA dates and FDA review timelines
- What is a PDUFA date and when does the FDA decide?
- A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to decide on a drug application (NDA or BLA). Standard Review is 10 months from submission acceptance; Priority Review is 6 months. The FDA aims to issue a decision — Approval, Complete Response Letter (CRL), or extension — by this date. TheraRadar currently tracks 47 upcoming PDUFAs.
- What happens if the FDA misses the PDUFA date?
- The FDA may extend the PDUFA date by 3 months (a "major amendment extension") when the sponsor submits significant new information late in the review cycle. Less commonly, the FDA issues a Complete Response Letter (CRL) outlining deficiencies — the sponsor must resubmit to restart the clock. Approximately 10–15% of applications receive CRLs rather than approvals on the original PDUFA date.
- What's the difference between a PDUFA date and an AdCom meeting?
- An Advisory Committee (AdCom) meeting is a panel of outside experts that reviews a drug application and votes on whether the FDA should approve it. AdComs are not always required — they happen for complex, controversial, or first-in-class drugs. The AdCom vote is non-binding but the FDA usually follows it. AdComs typically occur 2–4 months before the PDUFA date, making them earlier catalysts than the PDUFA decision itself.
- What's the difference between Priority Review and Standard Review?
- Priority Review (6-month PDUFA) is granted when a drug offers significant improvement over existing options for a serious condition — e.g., first-in-class mechanisms, breakthrough therapies, orphan drugs. Standard Review (10-month PDUFA) applies to drugs that primarily duplicate existing therapies. Priority Review also waives the user fee for the sponsor. Roughly 25–35% of NMEs receive Priority Review.
- Why are some recent PDUFA dates missing from this calendar?
- TheraRadar's PDUFA calendar is built primarily from public SEC 8-K filings where companies disclose FDA acceptance of their drug applications. This misses: (1) private companies not subject to SEC filing, (2) foreign-listed sponsors that file 6-Ks rather than 8-Ks, (3) supplementary BLAs (sBLAs) that companies sometimes don't 8-K, and (4) sponsors that disclose only via press release. We supplement SEC data with manually curated entries from press releases and earnings transcripts. If you spot a missing PDUFA, use the "Report wrong date" button above.
- How often is the PDUFA calendar updated?
- The PDUFA calendar refreshes weekly — TheraRadar pulls the latest SEC 8-K filings and matches them against the manual override list. Past PDUFA dates whose outcomes are known are also marked. Last updated: September 20, 2026.
Data Collection Methodology
- Search SEC EDGAR for 8-K filings containing "PDUFA"
- Extract PDUFA target dates using pattern matching
- Parse drug names from filing context where available
- Deduplicate by company (keeping most recent filing)
Limitations: Not all companies file 8-Ks announcing PDUFA dates. Some dates may be from historical context in filings. Drug names may not always be extractable.