Upcoming PDUFA dates
MYQORZO: PDUFA target action date (symptomatic obstructive HCM (based on MAPLE-HCM, vs. metoprolol))
Cytokinetics Inc (CYTK); aficamten; sNDA; status: set; "…F: heart failure with preserved ejection fraction; HFrEF: heart failure with reserved ejection fraction 5 Positioned for Launch & Sustainable Growth COMMERCIAL RESEARCH & DEVELOPMENT STRONG FINANCIAL POSITION Specialty Muscle-directed platform Cardiology ~$1.1B with multi-program pipeline Franchise cash, cash…"; filed 2026-05-05 · source
IGALMI: PDUFA target action date (acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting)
BioXcel Therapeutics, Inc. (BTAI); dexmedetomidine; sNDA; status: set; "In the quarter ended on March 31, the FDA accepted the Company’s supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026."; filed 2026-05-15 · source
ivonescimab: PDUFA target action date (EGFR-mutated locally advanced or metastatic non-squamous NSCLC after prior EGFR TKI therapy (with chemotherapy))
Summit Therapeutics Inc. (SMMT); ivonescimab; BLA; status: set; "The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026."; filed 2026-11-04 · source
Deramiocel: PDUFA target action date (Duchenne muscular dystrophy (DMD))
Capricor Therapeutics, Inc. (CAPR); BLA; status: extended; "Capricor Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update ● Deramiocel Biologics License Application (BLA) for Duchenne muscular dystrophy (DMD) under FDA review; PDUFA target action date of November 22, 2026 ● Major BLA amendment added two-year open-label extension (OLE)…"; filed 2026-11-10 · source
BBP-418: PDUFA target action date (limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9))
BridgeBio Pharma, Inc. (BBIO); NDA; status: set; "The first participant was dosed in ASCEND-ATTR, the Phase 3b/4 study to prospectively test disease reversal with Attruby - BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review."; filed 2026-10-29 · source
neladalkib: PDUFA target action date (ALK-positive non-small cell lung cancer)
Royalty Pharma plc (RPRX); NDA; status: set; "In May 2026, Nuvalent announced the FDA accepted its NDA for neladalkib for filing and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of November 27, 2026."; filed 2026-08-05 · source
povetacicept: PDUFA target action date (IgA nephropathy (IgAN), accelerated approval)
Vertex Pharmaceuticals Inc / Ma (VRTX); povetacicept; BLA; status: set; "FDA, with an assigned PDUFA target action date of November 30, 2026."; filed 2026-11-02 · source
bezuclastinib: PDUFA target action date (Gastrointestinal Stromal Tumors (GIST))
Cogent Biosciences, Inc. (COGT); bezuclastinib; status: set; "Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2026 Financial Results Preparing for anticipated bezuclastinib launch in GIST; PDUFA action date November 30, 2026 NonAdvSM PDUFA target action date December 30, 2026; AdvSM PDUFA target action date June 29, 2027 Cash balance of $791.1 million…"; filed 2026-11-05 · source
Povetacicept: PDUFA target action date (immunoglobulin A nephropathy (IgAN) in adults, accelerated approval)
Zai Lab Ltd (ZLAB); povetacicept; BLA; status: set; "…Povetacicept (pove, APRIL/BAFF): In June 2026, Zai Lab partner Vertex announced that the FDA accepted its BLA submission for pove for accelerated approval in adults with immunoglobulin A nephropathy (IgAN), with a PDUFA target action date of November 30, 2026."; filed 2026-08-06 · source
imsidolimab: PDUFA target action date (Generalized Pustular Psoriasis (GPP))
Vanda Pharmaceuticals Inc. (VNDA); imsidolimab; BLA; status: set; "…Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026"; filed 2026-05-06 · source
Quimilza: PDUFA target action date (Generalized Pustular Psoriasis (GPP))
Vanda Pharmaceuticals Inc. (VNDA); imsidolimab; BLA; status: set; "…Quimilza TM BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026"; filed 2026-10-28 · source
relacorilant: PDUFA target action date (Cushing's syndrome)
Corcept Therapeutics Inc (CORT); relacorilant; NDA; status: set; "…Relacorilant for patients with Cushing’s syndrome – Resubmitted New Drug Application Prescription Drug User Fee Act (PDUFA) date of December 17, 2026 “The ADA and EASD consensus statement is an important advance for the many patients whose difficult-to-control hyperglycemia is a manifestation of undiagnosed…"; filed 2026-11-03 · source
lorundrostat: PDUFA target action date (hypertension in combination with other antihypertensive drugs)
Mineralys Therapeutics, Inc. (MLYS); lorundrostat; NDA; status: set; "Mineralys Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update – Commercialization plans for lorundrostat are on track ahead of PDUFA target date of December 22, 2026 – – New analyses from the pivotal Launch-HTN trial showed 46% of participants with uncontrolled or resistant…"; filed 2026-11-04 · source
anito-cel: PDUFA target action date (fourth-line relapsed/refractory multiple myeloma)
Arcellx, Inc. (ACLX); anitocabtagene autoleucel; BLA; status: set; "Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026."; filed 2026-02-23 · source
anito-cel: PDUFA target action date (4L+ relapsed or refractory multiple myeloma)
Gilead Sciences, Inc. (GILD); anitocabtagene autoleucel; BLA; status: set; "…Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026."; filed 2026-05-07 · source
MR-107A-02: PDUFA target action date (moderate-to-severe acute pain)
Viatris Inc (VTRS); meloxicam; NDA; status: set; "The FDA has assigned a PDUFA goal date of December 27, 2026."; filed 2026-08-06 · source
relutrigine: PDUFA target action date (SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs))
Praxis Precision Medicines, Inc. (PRAX); NDA; status: set; "Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2026 Financial Results FDA reviews of relutrigine, with PDUFA target action date of December 27, 2026, and ulixacaltamide HCI, with PDUFA target action date of January 29, 2027, are ongoing Topline results from the EMERAL"; filed 2026-11-09 · source
ANKTIVA: PDUFA target action date (BCG-unresponsive NMIBC with papillary disease without CIS (ANKTIVA plus BCG))
ImmunityBio, Inc. (IBRX); sBLA; status: set; "…The FDA accepted for review the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027 • Continued advancement across the clinical pipeline, with multiple…"; filed 2026-08-04 · source
z-rostudirsen: PDUFA target action date (exon 51 Duchenne muscular dystrophy (DMD))
Dyne Therapeutics, Inc. (DYN); zeleciment rostudirsen; BLA; status: set; "Dyne Therapeutics Reports Third Quarter 2026 Financial Results and Recent Business Highlights - Biologics License Application (BLA) for z-rostudirsen in exon 51 Duchenne muscular dystrophy (DMD) under priority review by FDA; PDUFA target action date of January 21, 2027 - - Additional one-year clinical data from…"; filed 2026-11-05 · source
INSMED Inc: PDUFA target action date
INSMED Inc (INSM); "$75.5M +2% Int’l $48.9M +21% Worldwide $124.4M +9% sNDA granted priority review by FDA, with PDUFA target action date of January 28, 2027 Intend to submit data to PMDA in Q4:26 to support potential Japan label expansion Expect to launch under expanded all MACLD label in the U.S."; filed 2026-10-29 · source
ulixacaltamide: PDUFA target action date (essential tremor)
Praxis Precision Medicines, Inc. (PRAX); ulixacaltamide HCl; NDA; status: set; "Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2026 Financial Results FDA reviews of relutrigine, with PDUFA target action date of December 27, 2026, and ulixacaltamide HCI, with PDUFA target action date of January 29, 2027, are ongoing Topline results from the EMERALD study of…"; filed 2026-11-09 · source
mitapivat: PDUFA target action date (sickle cell disease)
Agios Pharmaceuticals, Inc. (AGIO); mitapivat; sNDA; status: extended; "…New PDUFA goal date for mitapivat sickle cell disease sNDA set for February 1, 2027; company is launch-ready and in labeling discussions with FDA • 14 abstracts accepted at ASH 2026, including new clinic"; filed 2026-11-05 · source
Oral infigratinib: PDUFA target action date (achondroplasia)
BridgeBio Pharma, Inc. (BBIO); infigratinib; NDA; status: set; "Launch preparation is well advanced, with 70% of patients concentrated at MDA Care Centers, over 70% of which the field team has reached with a 90% target by PDUFA. Based on interactions with EU national health authorities, the Company intends to submit an MAA to the EMA in the first half of 2028 - Oral…"; filed 2026-10-29 · source
Verastem, Inc.: PDUFA target action date
Verastem, Inc. (VSTM); "…FDA decision on NDA for AVMAPKI FAKZYNJA CO - PACK Blister Pack by February 7, 2027."; filed 2026-11-05 · source
ZORYVE cream 0.05%: PDUFA target action date (mild to moderate atopic dermatitis in infants aged 3 to 24 months)
Arcutis Biotherapeutics, Inc. (ARQT); roflumilast; sNDA; status: set; "…FDA accepted sNDA for ZORYVE cream 0.05% to expand indication to include infants with mild to moderate atopic dermatitis aged 3 to 24 months and set target action date of February 23, 2027 • Completed enrollment of the Phase 2 trial of ZORYVE foam 0.3% in individuals with vitiligo with disclosure of topline"; filed 2026-08-05 · source
Zipalertinib: PDUFA target action date (EGFR exon 20 insertion NSCLC previously treated with platinum-based chemotherapy (accelerated approval, monotherapy))
Cullinan Therapeutics, Inc. (CGEM); zipalertinib; NDA; status: set; "An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027."; filed 2026-10-02 · source
QTORIN™ rapamycin: PDUFA target action date (microcystic lymphatic malformations)
Palvella Therapeutics, Inc. (PVLA); rapamycin; NDA; status: set; "patients1 Potentially first FDA approved mLM therapy February 28, 2027 PDUFA Target Action Date 2029+ Additional Potential Approvals in mTOR-Driven Diseases >300,000 U.S."; filed 2026-11-05 · source
Ligand Pharmaceuticals Inc: PDUFA target action date
Ligand Pharmaceuticals Inc (LGND); "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027."; filed 2026-10-29 · source
AD109 (Oxnimbi): PDUFA target action date (obstructive sleep apnea in adults)
Apnimed, Inc. (APMD); aroxybutynin and atomoxetine; NDA; status: set; "Food and Drug Administration (“FDA”) Accepted the NDA for AD109, with a proposed proprietary name Oxnimbi ™, and assigned a PDUFA target action date of February 28, 2027 • If approved, Oxnimbi has the potential to become the first oral pharmacologic therapy designed to address the neuromu"; filed 2026-09-08 · source
zanzalintinib: PDUFA target action date (previously treated metastatic colorectal cancer (in combination with atezolizumab))
Exelixis, Inc. (EXEL); zanzalintinib; NDA; status: extended; "Zanzalintinib GI Highlights Ongoing Regulatory Review of Zanzalintinib in Combination with Atezolizumab (Tecentriq ® ) for Previously Treated Metastatic CRC with Prescription Drug User Fee Act (PDUFA) Target Action Date of March 3, 2027."; filed 2026-10-29 · source
lonvo-z: PDUFA target action date (hereditary angioedema (HAE))
Intellia Therapeutics, Inc. (NTLA); lonvoguran ziclumeran; BLA; status: set; "Intellia Therapeutics Announces Third Quarter 2026 Financial Results and Business Updates - On track to complete lonvo-z commercial readiness efforts in advance of March 10, 2027 PDUFA date - New lonvo-z patient perspectives and Phase 1/2 durability data to be included in investor webcast and mult"; filed 2026-11-05 · source
Reblozyl: PDUFA target action date (myelofibrosis-associated anemia in adults receiving red blood cell transfusions, with concomitant JAK inhibitor therapy)
Bristol Myers Squibb Co (BMY); luspatercept; sBLA; status: set; "The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027."; filed 2026-07-30 · source
Anaphylm: PDUFA target action date
Aquestive Therapeutics, Inc. (AQST); dibutepinephrine; NDA; status: set; "Food and Drug Administration (“FDA”); our belief that the New Drug Application (“NDA”) resubmission addresses the matters identified by the FDA in the Complete Response Letter (“CRL”) dated January 30, 2026; the FDA’s review of the accepted Class 2 resubmission of the NDA and the Prescription Drug User Fee Act…"; filed 2026-11-05 · source
Merck & Co., Inc.: PDUFA target action date
Merck & Co., Inc. (MRK); "FDA set PDUFA date of March 22, 2027."; filed 2026-10-29 · source
Libervant: PDUFA target action date (acute treatment of seizure clusters/acute repetitive seizures in patients twelve years of age and older)
Aquestive Therapeutics, Inc. (AQST); diazepam; NDA; status: set; "Final FDA approval for patients twelve years of age and older is subject to expiration of the orphan drug exclusivity for Valtoco® on January 10, 2027, and final FDA action, with a PDUFA goal date of March 23, 2027."; filed 2026-11-03 · source
LIBERVANT: PDUFA target action date (seizure clusters in patients with epilepsy, adding ages 6 to 11 to the label)
Eton Pharmaceuticals, Inc. (ETON); diazepam; NDA; status: set; "The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027."; filed 2026-10-14 · source
tab-cel: PDUFA target action date (EBV+ post-transplant lymphoproliferative disease (PTLD) after at least one prior therapy)
Atara Biotherapeutics, Inc. (ATRA); tabelecleucel; BLA; status: set; "Atara Biotherapeutics Announces Third Quarter 2026 Financial Results and Operational Progress Prescription Drug User Fee Act (PDUFA) Target Action Date of March 31, 2027 Approval of BLA would unlock a $31 Million milestone payment from Pierre Fabre Laboratories Nine-month year over year reduction in costs and…"; filed 2026-11-10 · source
Pitolisant GR: PDUFA target action date
Harmony Biosciences Holdings, Inc. (HRMY); pitolisant; NDA; status: set; "…nd Pharmacokinetic Profile Observed in Single-Ascending Dose Study Results from Phase 1b Study in Sleep-Deprived Healthy Volunteers for BP-205 Remain on Track for Q1 2027; Phase 2 Studies in Multiple CNS Indications Expected to Initiate by Mid-2027 Pitolisant GR NDA Under FDA Review, PDUFA Date April 1, 2027;…"; filed 2026-11-04 · source
ozekibart (INBRX-109): PDUFA target action date (conventional chondrosarcoma)
Inhibrx Biosciences, Inc. (INBX); ozekibart; BLA; status: set; "Food and Drug Administration (FDA) accepted for filing the Company’s biologics license application (BLA) for the potential approval of ozekibart in conventional chondrosarcoma and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027."; filed 2026-08-13 · source
Epidiolex: PDUFA target action date (oral cannabidiol capsule formulation)
Jazz Pharmaceuticals plc (JAZZ); cannabidiol; NDA; status: set; "…The PDUFA target action date for our New Drug Application (NDA) for the oral cannabidiol capsule formulation is April 16, 2027."; filed 2026-11-02 · source
Merck & Co., Inc.: PDUFA target action date
Merck & Co., Inc. (MRK); "FDA set a PDUFA date for both sNDAs of April 22, 2027."; filed 2026-10-29 · source
deucrictibant immediate-release: PDUFA target action date (on-demand treatment of hereditary angioedema attacks)
Royalty Pharma plc (RPRX); deucrictibant; NDA; status: set; "deucrictibant In July 2026, Pharvaris announced that the FDA accepted its NDA for deucrictibant immediate-release for the on-demand treatment of hereditary angioedema attacks and assigned a PDUFA date of April 23, 2027."; filed 2026-08-05 · source
Varegacestat: PDUFA target action date (desmoid tumors)
Immunome Inc. (IMNM); NDA; status: set; "…Varegacestat PDUFA target action date of April 28, 2027; Marketing Authorization Application (MAA) validated by the European Medicines Agency (EMA) • Initial IM-1021 results s"; filed 2026-11-09 · source
AXS-12: PDUFA target action date (cataplexy in narcolepsy)
Axsome Therapeutics, Inc. (AXSM); reboxetine; NDA; status: set; "The PDUFA target action date is May 1, 2027."; filed 2026-11-02 · source
ifezuntirgene inilparvovec: PDUFA target action date (Huntington's disease)
uniQure N.V. (QURE); ifezuntirgene inilparvovec; BLA; status: set; "The application has been granted Priority Review with a Prescription Drug User Fee Act (“ PDUFA ”) target action date of May 1, 2027."; filed 2026-11-02 · source
AMT-130: PDUFA target action date (Huntington's disease)
uniQure N.V. (QURE); ifezuntirgene inilparvovec; BLA; status: set; "uniQure Announces Third Quarter 2026 Financial Results and Provides Company Update ~ FDA granted priority review of BLA for ifezuntirgene inilparvovec (AMT-130) in Huntington’s disease; PDUFA target action date of May 1, 2027 ~ ~ Aligned with FDA on key elements of confirmatory study design; U.S."; filed 2026-11-04 · source
Encaleret: PDUFA target action date (autosomal dominant hypocalcemia type 1 (ADH1))
BridgeBio Pharma, Inc. (BBIO); encaleret; status: set; "…achondroplasia has a February 4, 2027 PDUFA date, with Priority Review. The MAA is now under EMA review with potential EU approval in the second half of 2027. Launch preparation is well advanced, with the U.S. field team fully staffed. In hypochondroplasia, the Phase 2/3 ACCEL study is expanding to higher doses to…"; filed 2026-10-29 · source
mezigdomide: PDUFA target action date (relapsed or refractory multiple myeloma (in combination with carfilzomib and dexamethasone))
Bristol Myers Squibb Co (BMY); mezigdomide; NDA; status: set; "mezigdomide July 13 The FDA accepted a New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM), granting a PDUFA date of May 13, 2027."; filed 2026-07-30 · source
Royalty Pharma plc: PDUFA target action date
Royalty Pharma plc (RPRX); "obexelimab In August 2026, Zenas BioPharma announced that the FDA accepted for review its Biologics License Application for obexelimab for the treatment of immunoglobulin G4-related disease (IgG4-RD) and assigned a PDUFA target action date of May 27, 2027."; filed 2026-11-04 · source
Obexelimab: PDUFA target action date (IgG4-RD)
Zenas BioPharma, Inc. (ZBIO); BLA; status: set; "Zenas BioPharma Reports Third Quarter 2026 Financial Results and Provides Corporate Update - PDUFA target action date of May 27, 2027, following FDA acceptance of Obexelimab BLA submission for the treatment of IgG4-RD in second quarter 2026 - - Obexelim"; filed 2026-11-05 · source
VOXZOGO: PDUFA target action date (hypochondroplasia (HCH))
Biomarin Pharmaceutical Inc (BMRN); sNDA; status: set; "…2026 Total Revenues Increased 32% Y/Y to $1.025 billion; Growth Driven by 44% Increase in Metabolic Conditions Y/Y, and 12% Increase in Skeletal Conditions Y/Y Updates Full-year 2026 Guidance to Reflect Order Timing Uncertainty and Impact of Two Acquired In-process Research and Development (IPR&D) Charges Recently…"; filed 2026-11-02 · source
UGN-103: PDUFA target action date (recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC))
UroGen Pharma Ltd. (URGN); mitomycin; NDA; status: set; "…The FDA accepted UroGen ’ s NDA for UGN-103 (next-generation novel mitomycin-based formulation) for review; PDUFA goal date set for June 14, 2027 • Announced first patient dosed in the UGN-501 Phase 1 trial • Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Nov."; filed 2026-11-04 · source
Merck & Co., Inc.: PDUFA target action date
Merck & Co., Inc. (MRK); "FDA set Prescription Drug User Fee Act (PDUFA) date of June 15, 2027."; filed 2026-10-29 · source
FDA advisory committee meetings
Microbiology Devices Panel of the Medical Devices Advisory Committee
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. In addition, the Committee will meet to discuss and provide advice to FDA on examining the scientific, clinical, and public health dimensions of the use of pathogen-agnostic sequencing as it relates to emergency preparedness and response efforts, and to support discussion of opportunities, implementation considerations, a · source
Recent PDUFA dates (last 120 days)FDA approvals →
INO-3107: PDUFA target action date (Recurrent Respiratory Papillomatosis (RRP))
Inovio Pharmaceuticals, Inc. (INO); BLA; status: set; "Food and Drug Administration (FDA) review of Biologics License Application (BLA) for INO-3107 as a treatment for Recurrent Respiratory Papillomatosis (RRP) advancing with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 • Commercial preparations advancing in anticipation of potential product…"; filed 2026-08-12 · source
bepirovirsen: PDUFA target action date (chronic hepatitis B)
Ionis Pharmaceuticals Inc (IONS); bepirovirsen; empty; status: set; "and PDUFA target action date of October 26, 2026 o Positive data from the Phase 3 B-Well studies showing unprecedented functional cure rates presented at the European A"; filed 2026-07-29 · source
Phentolamine Ophthalmic Solution 0.75%: PDUFA target action date (presbyopia)
Opus Genetics, Inc. (IRD); phentolamine; sNDA; status: set; "…The FDA accepted the Company’s supplemental New Drug Application (sNDA) for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia and set a PDUFA action date of October 17, 2026."; filed 2026-03-10 · source
MR-141: PDUFA target action date (presbyopia)
Viatris Inc (VTRS); phentolamine ophthalmic solution 0.75%; sNDA; status: set; "The FDA has assigned a PDUFA goal date of October 17, 2026."; filed 2026-02-26 · source
Unicycive Therapeutics, Inc.: PDUFA target action date
Unicycive Therapeutics, Inc. (UNCY); "…12 months of OLC drug product stability data from the new manufacturing vendor - Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission - Current cash position allows runway into 2H 2027 MOUNTAIN VIEW, Calif., September 29,…"; filed 2026-09-29 · source
Ameluz: PDUFA target action date (superficial basal cell carcinoma (sBCC))
Biofrontera Inc. (BFRI); sNDA; status: set; "Recent Operational Highlights ● Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz ® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026."; filed 2026-05-14 · source
zilurgisertib: PDUFA target action date (fibrodysplasia ossificans progressiva (FOP))
Mirum Pharmaceuticals, Inc. (MIRM); zilurgisertib; NDA; status: set; "…Presented positive pivotal Phase 2 results from the PROGRESS study of zilurgisertib in fibrodysplasia ossificans progressiva (FOP) at ENDO 2026; Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026."; filed 2026-08-05 · source
zilganersen: PDUFA target action date (Alexander disease)
Ionis Pharmaceuticals Inc (IONS); zilganersen; NDA; status: set; "…Zilganersen on track to launch this year as the first and only medicine to demonstrate clinically meaningful and disease-modifying benefit in children and adults with Alexander disease (AxD), assuming approval o New Drug Application (NDA) under FDA Priority Review with PDUFA target action date of September 22,…"; filed 2026-07-29 · source
UX111: PDUFA target action date (Sanfilippo syndrome type A (MPS IIIA))
Ultragenyx Pharmaceutical Inc. (RARE); rebisufligene etisparvovec; BLA; status: set; "…UX111 (rebisufligene etisparvovec) AAV9 gene therapy for the treatment of Sanfilippo syndrome type A (MPS IIIA): In April 2026, the FDA accepted for review the resubmitted BLA seeking accelerated approval for UX111 as a treatment for MPS IIIA and assigned a PDUFA action date of September 19, 2026."; filed 2026-08-04 · source
zidesamtinib: PDUFA target action date (TKI pre-treated advanced ROS1-positive NSCLC)
Nuvalent, Inc. (NUVL); zidesamtinib; NDA; status: set; "…peline Progress, Reiterates Key Anticipated Milestones, and Reports First Quarter 2026 Financial Results NDA submitted for neladalkib in TKI pre-treated advanced ALK-positive NSCLC NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC under FDA review with PDUFA target action date of September 18,…"; filed 2026-05-07 · source
BIC/LEN: PDUFA target action date (virologically suppressed people with HIV)
Gilead Sciences, Inc. (GILD); bictegravir and lenacapavir; NDA; status: set; "Food and Drug Administration (“FDA”) accepted New Drug Application for bictegravir and lenacapavir (“BIC/LEN”) for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 27, 2026."; filed 2026-05-07 · source
Ziihera: PDUFA target action date (first-line HER2+ gastroesophageal adenocarcinoma (GEA))
Jazz Pharmaceuticals plc (JAZZ); zanidatamab-hrii; sBLA; status: set; "Food and Drug Administration (FDA) granted Priority Review and set Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026 for supplemental Biologics License Application (sBLA) for zanidatamab containing combinations in first-line (1L) gastroesophageal adenocarcinoma (GEA)."; filed 2026-08-03 · source
Ziihera: PDUFA target action date (first-line HER2-positive unresectable locally advanced or metastatic gastric, GEJ, or gastroesophageal adenocarcinoma (G)
Zymeworks Inc. (ZYME); zanidatamab-hrii; sBLA; status: set; "FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA); PDUFA target action date of August 25, 2026 • China’s NMPA has accepted the sBLA for zanidatamab;…"; filed 2026-05-07 · source
DTX401: PDUFA target action date (glycogen storage disease type Ia (GSDIa))
Ultragenyx Pharmaceutical Inc. (RARE); pariglasgene brecaparvovec; BLA; status: set; "Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) seeking approval of DTX401 as a treatment for GSDIa and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 23, 2026."; filed 2026-08-04 · source
iberdomide: PDUFA target action date (relapsed or refractory multiple myeloma)
Bristol Myers Squibb Co (BMY); iberdomide; status: set; "Mezigdomide is the second BMS CELMoD to be granted a PDUFA date this year for an RRMM indication, joining iberdomide , which has a PDUFA date of August 17, 2026."; filed 2026-07-30 · source
Pfizer Inc: PDUFA target action date
Pfizer Inc (PFE); "The FDA has set a PDUFA target action date of August 17, 2026."; filed 2026-05-05 · source
MK-6240: PDUFA target action date (tau-targeted PET imaging for Alzheimer's disease diagnostics)
Lantheus Holdings, Inc. (LNTH); NDA; status: set; "The FDA has set a PDUFA target action date of August 13, 2026."; filed 2025-11-06 · source
mRNA-1010: PDUFA target action date (seasonal influenza vaccine)
Moderna, Inc. (MRNA); status: set; "FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026."; filed 2026-05-01 · source
low-dose estrogen weekly patch: PDUFA target action date (contraception)
Viatris Inc (VTRS); norelgestromin and ethinyl estradiol; NDA; status: set; "The NDA was accepted under the FDA's 505(b)(2) regulatory pathway, and the FDA has assigned a PDUFA goal date of July 30, 2026."; filed 2026-02-26 · source
ONS-5010/LYTENAVA: PDUFA target action date (neovascular age-related macular degeneration (wet AMD))
Outlook Therapeutics, Inc. (OTLK); bevacizumab-vikg; BLA; status: set; "Exhibit 99.1 Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026"; filed 2026-06-16 · source
ONS-5010: PDUFA target action date
Outlook Therapeutics, Inc. (OTLK); bevacizumab-vikg; BLA; status: set; "The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026."; filed 2026-06-16 · source
Furoscix ReadyFlow Autoinjector: PDUFA target action date
Mannkind Corp (MNKD); furosemide injection; status: set; "Q1 2025 Built out launch infrastructure and aligned field-based teams for upcoming launches Settlement of senior convertible notes of $36.3M Program updates: Afrezza ® pediatric indication PDUFA date May 29, 2026 Furoscix ReadyFlow ™ Autoinjector PDUFA date July 26, 2026 Nintedanib DPI (MNKD-201) for…"; filed 2026-05-06 · source
gedatolisib: PDUFA target action date (HR+/HER2- PIK3CA wild-type advanced or metastatic breast cancer)
Celcuity Inc. (CELC); gedatolisib; NDA; status: set; "The FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2- PIK3CA wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026."; filed 2026-06-02 · source
A past PDUFA date doesn't tell you the outcome. Check the FDA approvals list or the company's announcement.
How these dates are found: FDA doesn't publish PDUFA goal dates. Companies announce them in press releases filed with the SEC (Form 8-K). VigiEye reads those filings and links each date to the filing it came from. The most recent filing wins when a date is extended.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.