FDA Calendar - PDUFA Dates & AdCom Meetings
34 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: November 8, 2026
Upcoming PDUFA Dates by Month
November 2026
December 2026
January 2027
February 2027
March 2027
April 2027
May 2027
August 2027
Recent Decisions (Last 6 Months)
50 approved, 8 pending outcome
November 2026
Agios IR release dated 2026-07-07, subhead 'FDA's PDUFA goal date is November 1, 2026': the FDA accepted the sNDA for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with Priority Review; the sNDA was submitted under the FDA's accelerated approval pathway and is supported by the global Phase 2/3 RISE UP program in patients aged 16+. Independently corroborated in Agios' 10-Q filed 2026-07-30 (https://www.sec.gov/Archives/edgar/data/1439222/000143922226000118/agio-20260630.htm): 'We submitted a supplemental New Drug Application, or sNDA, for the U.S. accelerated approval of mitapivat in sickle cell disease, or SCD, in May 2026, which was accepted with priority review by the FDA and granted a Prescription Drug User Fee Act, or PDUFA, goal date of November 1, 2026.' Phase 3 REIGNITE is the confirmatory trial. If approved, first oral PK activator in SCD. RESOLVES the pdufa-calendar.json parse-error row 'AGIOS PHARMACEUTICALS ... drugName: null, November 1, 2026'. No AdCom mentioned.
October 2026
DRUG NAME CORRECTED: was wrongly listed as VGX-3100, which was discontinued in US in Aug 2023. Actual PDUFA is for INO-3107, a different Inovio asset, DNA immunotherapy for RRP.
GSK press release dated April 28, 2026: '26 October 2026 assigned by FDA as PDUFA date' and 'The FDA has assigned 26 October 2026 as the Prescription Drug User Fee Act (PDUFA) goal date.' FDA accepted the NDA for priority review and granted Breakthrough Therapy Designation, added to the Fast Track Designation granted February 2024. Bepirovirsen is an investigational antisense oligonucleotide licensed from Ionis Pharmaceuticals; supported by the Phase III B-Well 1 and B-Well 2 trials showing statistically significant functional cure rates. Primary SEC copy of the same release: https://www.sec.gov/Archives/edgar/data/1131399/000165495426003977/a1144c.htm (GSK plc Form 6-K, filed 2026-04-28). Partner Ionis independently reports the same date in its 8-K/10-Q filings of 2026-04-29 and 2026-07-29 ('PDUFA target action date of October 26, 2026').
Approved 2026-09-11 (about 6 weeks early) as JOENJA sNDA (SUPPL-6, EFFICACY in drugs.json): 40 mg and 50 mg twice-daily dosing for children aged 4 to 11 years weighing at least 27 kg with APDS. Pharming plans a separate sNDA for lower doses (13-27 kg). Source: https://www.sec.gov/Archives/edgar/data/0001828316/000182831626000037/fdaapprovespharmingsjoenja.htm
NDA filed Dec 18, 2025. Standard review (10 months). REDEFINE 1: 22.7% mean weight reduction. First GLP-1 + amylin combination. PDUFA date estimated (~10 months from filing). [DATE CAVEAT 2026-06-30: Novo discloses only "review expected in 2026"; the Oct 18 day is an aggregator estimate, not company-confirmed.] [QUARTER ONLY 2026-08-02: Novo Nordisk Q1 2026 6-K milestone table lists CagriSema 'US decision' under Q4 2026, not October. The stored day equals submission + 10 months, which is the wrong clock (a standard NME review runs 10 months from the 60-day filing date). Treat the month as unconfirmed.] [DATE UNVERIFIED 2026-10-06: No primary source discloses an exact PDUFA day. Novo filing release (2025-12-18) says only that FDA is expected to review CagriSema in 2026; Novo Q2 2026 report lists the US decision under Q4 2026. Oct 18 is a filing-date + 10-month estimate. Source: https://www.sec.gov/Archives/edgar/data/0000353278/000035327826000023/caq22026.htm]
Company also developing gene therapies for inherited retinal diseases (OPGx-LCA5, OPGx-BEST1)
Genentech press release dated June 29, 2026: FDA granted Priority Review to the sBLA for Enspryng (satralizumab) in thyroid eye disease, with an FDA decision expected by October 15, 2026. Based on the Phase III SatraGO-1 and SatraGO-2 studies showing improvements in proptosis and diplopia in active TED. Enspryng is an IL-6 receptor-directed antibody already approved for AQP4-IgG seropositive NMOSD; if approved in TED it would be the first and only at-home subcutaneous treatment option for the indication. (The orphan drug designations Genentech cites are for NMOSD/MOGAD/AIE, not TED, so only Priority Review is recorded here.) [UPDATE 2026-10-06: Roche release of 2026-09-10 restates the TED decision as expected in October 2026 (the exact 15 October date is from the 2026-06-30 release). Source: https://www.roche.com/media/releases/med-cor-2026-09-10]
BLA voluntarily withdrawn, announced 2026-09-25: FDA indicated the IDeate-Lung01 Phase 2 data do not satisfy requirements to support accelerated approval for the proposed indication. Development continues in Phase 3 IDeate-Lung02. Source: https://www.merck.com/news/ifinatamab-deruxtecan-biologics-license-application-for-certain-patients-with-previously-treated-extensive-stage-small-cell-lung-cancer-voluntarily-withdrawn/
sBLA accepted + Priority Review (Jun 10, 2026); based on Phase III ATOMIC.
Approved 2026-09-24 as WELIREG (SUPPL NDA215383). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 10d from the PDUFA date.
September 2026
Approved 2026-08-27 as LISRAYA (ORIG NDA220106). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 34d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
Approved 2026-09-11 as ISEMBYLD (ORIG BLA761463). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 19d from the PDUFA date.
Approved 2026-09-30 as CAMZYOS (SUPPL NDA214998). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Approved 2026-09-28 as EMCITATE (ORIG NDA220963). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Approved 2026-09-09 as AMELUZ (SUPPL NDA208081). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 19d from the PDUFA date.
Approved 2026-09-23 as LYRFIGTU (ORIG NDA220425). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 4d from the PDUFA date.
Approved 2026-09-25 as ATEBRIOZ (ORIG NDA221198). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 1d from the PDUFA date.
Approved 2026-09-03 as ZANVASTRO (ORIG NDA220210). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 19d from the PDUFA date.
Approved 2026-09-21 as WINREVAIR (SUPPL BLA761363). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Approved 2026-09-18 as AQNEURSA (SUPPL NDA219132). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 1d from the PDUFA date.
Full approval as FAYUVI (rebisufligene etisparvovec-hopf) for pediatric MPS IIIA (Sanfilippo syndrome type A); reported in Ultragenyx 8-K dated 2026-09-17. CBER product, not yet in drugs.json. Source: https://www.sec.gov/Archives/edgar/data/0001515673/000151567326000006/rare-20260917.htm
Approved 2026-09-11 as PIXCLARA (ORIG NDA218592). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Advicenne voluntarily withdrew the US NDA on 2026-08-31: additional CMC work could not be completed within the current review cycle. Source: Advicenne press release https://ca.finance.yahoo.com/news/advicenne-decides-withdraw-adv7103-drug-050000148.html
August 2026
Approved 2026-08-28 as MIMRYLO (ORIG NDA220605). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 3d from the PDUFA date.
Approved 2026-08-28 as BESREMI (SUPPL BLA761166). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 2d from the PDUFA date.
CRL received 2026-08-07 (announced 2026-08-10): CMC and third-party commercial facility inspection items; no clinical safety or efficacy issues identified and no additional clinical or nonclinical data requested. ITM plans to resubmit. Source: https://www.globenewswire.com/news-release/2026/08/10/3341933/0/en/itm-receives-complete-response-letter-for-lu-edotreotide-itm-11.html
Approved 2026-08-27 as BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) (ORIG NDA221443). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Approved 2026-08-25 as ZIIHERA (SUPPL BLA761416). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.
Approved 2026-07-13 (42 days early) as LEQEMBI IQLIK sBLA (SUPPL-1, EFFICACY, BLA761375 in drugs.json): once-weekly subcutaneous initiation dose for early Alzheimer disease. BLA held by Eisai (Biogen is the 50/50 partner). Source: Eisai press release https://media-us.eisai.com/2026-07-13-FDA-Approves-LEQEMBI-IQLIK-R-lecanemab-irmb-Subcutaneous-Injection-as-an-Initiation-Dose-for-Early-Alzheimers-Disease
Accelerated approval 2026-08-19 as GENGLYCOS (pariglasgene brecaparvovec-opnr) for GSDIa in patients 8 years and older. CBER product, not yet in drugs.json. Source: https://www.globenewswire.com/news-release/2026/08/19/3348019/0/en/ultragenyx-announces-u-s-fda-approval-of-genglycos-gene-therapy-the-first-ever-fda-approved-treatment-designed-to-treat-the-underlying-cause-of-glycogen-storage-disease-type-ia-gsd.html ; 8-K https://www.sec.gov/Archives/edgar/data/1515673/000119312526357185/rare-20260819.htm
PDUFA extended 3 months from 2026-08-22 to 2026-11-22: FDA classified the submission of 24-month HOPE-3 open-label extension data and analyses supporting a refined upper-limb indication as a major amendment. Source: Capricor 8-K 2026-08-24 https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm
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.
Approved 2026-08-13 as TAUKLARIFY (florquinitau F 18 injection; NDA220496 in drugs.json), announced 2026-08-14. Not auto-resolved: the entry uses only the code MK-6240. Source: https://www.globenewswire.com/news-release/2026/08/14/3345281/0/en/lantheus-announces-fda-approval-of-tauklarify-florquinitau-f-18-injection-an-f18-labeled-tau-pet-imaging-agent-for-alzheimer-s-disease.html
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.
Approved 2026-08-05 as mFLUSIVA for adults 50+ (full approval 50-64; accelerated approval 65+, pending a confirmatory postmarketing study). CBER product, not yet in drugs.json. Source: Moderna press release https://feeds.issuerdirect.com/news-release.html?newsid=4801915282452025&symbol=MRNA
Accelerated approval as TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for unresectable advanced cutaneous melanoma after progression on an anti-PD-1 regimen; announced 2026-08-06. CBER product, not yet in drugs.json. Source: https://www.globenewswire.com/news-release/2026/08/06/3340656/0/en/replimune-announces-fda-accelerated-approval-of-tudriqevtm-in-combination-with-nivolumab-for-unresectable-advanced-cutaneous-melanoma-after-progression-on-an-anti-pd-1-based-regime.html
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.
Approved 2026-09-25 as JUVMO (ORIG NDA220415). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 61d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
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
Approved 2026-05-22 (39 days early) as DATROWAY sBLA (SUPPL-3, EFFICACY, BLA761394 in drugs.json) for unresectable or metastatic TNBC in adults who are not candidates for PD-1/PD-L1 inhibitor therapy, based on TROPION-Breast02. Source: Daiichi Sankyo press release, Tokyo, May 22, 2026 https://www.daiichisankyo.com/files/news/pressrelease/pdf/202605/20260522_E2.pdf ; AstraZeneca https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-approved-in-us-for-1l-triple-negative-bc.html
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 2026-06-12 (7 days early): KEYTRUDA (SUPPL-192, BLA125514) and KEYTRUDA QLEX, each with WELIREG (SUPPL-15, NDA215383), for adjuvant treatment of certain patients with clear cell RCC after nephrectomy, based on LITESPARK-022. Corrected 2026-10-06 from primary source: earlier auto-resolutions named KEYTRUDA QLEX and then a KEYTRUDA supplement dated 2026-06-24 (SUPPL-187, a different decision) because the old matcher took the approval closest in date and let a combination backbone settle the entry. Source: https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-welireg-belzutifan-for-adjuvant-treatment-of-certain-patients/
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/
Approved 2026-05-15 as BAXFENDY (ORIG NDA219878). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 31d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
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/
Approved 2026-05-01 as VEPPANU (ORIG NDA219835). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 35d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
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).
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 34 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: November 8, 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.