Company | Product | Description | Indication | Filing type | PDUFA (Prescription Drug User Fee Act) date |
Notes (* = estimated date) |
Evergreen Theragnostics Inc., of Springfield, N.J. | Gallium-68 DOTATOC injection | Radiopharmaceutical | Neuroendocrine tumors | NDA | 7/20/2023 | *2H:2023 |
Vyluma Inc., of Bridgewater, N.J. | NVK-002 | Low-dose atropine (0.01%) | Myopia | NDA | 1/31/2024 | |
Accord Biopharma Inc., of Durham, N.C., and Henlius Biotech Inc., of Shanghai | HLX-02 | Trastuzumab biosimilar | HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma | BLA | 2/5/2024 | * |
Astrazeneca plc, of London | Flumist Quadrivalent | Protein-based vaccine | Influenza prophylaxis | sBLA | 3/31/2024 | * |
Xbrane Biopharma AB, of Solna, Sweden | Lucentis (ranibizumab) biosimilar candidate | VEGF-A inhibitor | Wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion and myopic choroidal neovascularization | sBLA | 4/21/2024 | |
Immunitybio Inc., of Culver City, Calif. | N-803 | IL-15 superagonist | Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma | BLA | 4/23/2024 | |
Utility Therapeutics Ltd., of London | Pivmecillinam | Oral prodrug of mecillinam | Uncomplicated urinary tract infection | NDA (Priority) | 4/24/2024 | |
Pfizer Inc., of New York | Fidanacogene elaparvovec | Gene therapy | Hemophilia B | BLA (Breakthrough; Regenerative Medicines Advanced Therapy; orphan) | 4/27/2024 | *Q2:2024 |
Aquestive Therapeutics Inc., of Warren, N.J. | Libervant | Buccal film formulation of diazepam | Intermittent, stereotypic episodes of frequent seizure activity | NDA | 4/28/2024 | |
Pharmather Holdings Ltd., of Toronto | Ketarx (ketamine) | Non-barbiturate anesthetics | Anesthesia, sedation, pain, mental health, and neurological indication | ANDA (Priority) | 4/29/2024 | |
X4 Pharmaceuticals Inc., of Boston | Oral mavorixafor | Small-molecule antagonist of the CXCR4 receptor | WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome | NDA | 4/30/2024 | |
Moderna Inc., of Cambridge, Mass. | mRNA-1345 | Vaccine consisting of mRNA encoding for a stabilized RSV prefusion F glycoprotein, encapsulated in lipid nanoparticles; single-dose vaccine | Respiratory syncytial virus | BLA (Priority) | 5/12/2024 | *4/2024 |
Neurocrine Biosciences Inc., of San Diego | Ingrezza (valbenazine) | VMAT2 inhibitor; oral granules; sprinkle formulation | Tardive dyskinesia | NDA | 4/30/2024 | |
Day One Biopharmaceuticals, of Brisbane, Calif. | Tovorafenib | Oral, brain-penetrant, highly selective type II RAF kinase inhibitor | Relapsed or progressive pediatric low-grade glioma | NDA (Priority) | 4/30/2024 | |
Seagen Inc., of Bothell, Wash., and Astellas Pharma Inc., of Tokyo | Padcev (enfortumab vedotin-ejfv) | Antibody-drug conjugate directed against Nectin-4 | Advanced or metastatic urothelial cancer | sBLA (Priority) | 5/9/2024 | |
Genmab A/S, of Copenhagen, Denmark, and Pfizer Inc., of New York | Tivdak (tisotumab vedotin-tftv) | ADC composed of human monoclonal antibody targeted toward tissue factor with a protease-cleavable linker covalently attached to microtubule-disrupting agent monomethyl auristatin E | Recurrent or metastatic cervical cancer | sBLA | 5/9/2024 | |
Dynavax Technologies Corp., of Emeryville, Calif. | Heplisav-B | Vaccine that combines hepatitis B surface antigen with Dynavax's TTLR 9 agonist adjuvant CpG 1018 | For Heplisav-B vaccination of adults on hemodialysis | sBLA | 5/13/2024 | |
Elevar Therapeutics Inc., of Fort Lee, N.J. | Rivoceranib and camrelizumab (SHR-1210) | Orally administered tyrosine kinase inhibitor and humanized monoclonal antibody targeting PD-1 | Unresectable hepatocellular carcinoma | NDA | 5/16/2024 | |
Bristol Myers Squibb Co., of Princeton, N.J. | Breyanzi (lisocabtagene maraleucel) | CD19-directed CAR T-cell therapy with a 4-1BB costimulatory domain | Relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma | sBLA (Priority) | 5/23/2024 | |
Boehringer Ingelheim GmbH, of Germany | Ofev (nintedanib) | Small-molecule tyrosine kinase inhibitor | Fibrosing interstitial lung disease | sNDA | 5/25/2024 | * |
Abeona Therapeutics Inc., of Cleveland | Prademagene zamikeracel | Autologous, COL7A1 gene-corrected epidermal sheets | Recessive dystrophic epidermolysis bullosa | BLA | 5/25/2024 | |
Catalyst Pharmaceuticals Inc., of Coral Gables, Fla. | Firdapse (amifampridine) | Voltage-dependent potassium channel blocker | Lambert-Eaton myasthenic syndrome | sNDA | 6/4/2024 | |
GSK plc, of London | Arexvy (recombinant adjuvanted vaccine; RSVPreF3) | Vaccine, adjuvanted; contains recombinant glycoprotein F stabilized in the prefusion conformation | Lower respiratory tract disease caused by respiratory syncytial virus infection | sBLA (Priority) | 6/7/2024 | |
Mediwound Ltd., of Yavne, Israel | Nexobrid | Botanical drug product containing proteolytic enzymes | Thermal burns | sBLA | 6/9/2024 | |
Ipsen SA, of Paris, and Genfit SA, of Lille, France | Elafibranor | Oral, dual PPAR ?,? agonist | Primary biliary cholangitis | NDA (Priority) | 6/10/2024 | |
Amgen Inc., of Thousand Oaks, Calif. | AMG-757 (tarlatamab) | Half-life extended bispecific T-cell engager molecule designed to target delta-like ligand 3 | Advanced small-cell lung cancer | BLA (Priority) | 6/12/2024 | |
CSL Behring, a unit of Melbourne, Australia-based CSL Ltd. | CSL-312 (garadacimab) | Monoclonal antibody targeting factor XIIa | Hereditary angioedema | BLA (Orphan) | 6/14/2024 | * |
Bristol Myers Squibb Co., of Princeton, N.J. | Augtyro (repotrectinib) | Tyrosine kinase inhibitor targeting ROS1 or NTRK | Solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion | sNDA | 6/15/2024 | |
Geron Corp., of Foster City, Calif. | Imetelstat | Telomerase inhibitor | Transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes | NDA (Standard) | 6/16/2024 | |
Merck & Co. Inc., of Rahway, N.J. | V-116 | 21-valent pneumococcal conjugate vaccine | Invasive pneumococcal disease and pneumococcal pneumonia | BLA (Priority) | 6/17/2024 | |
Argenx SE, of Amsterdam | Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | Subcutaneous combination of efgartigimod alfa (human IgG1 antibody fragment) and recombinant human hyaluronidase PH20 | Chronic inflammatory demyelinating polyneuropathy | sBLA (Priority) | 6/21/2024 | |
Bristol Myers Squibb Co., of Princeton, N.J. | Krazati (adagrasib) | Oral small-molecule inhibitor of KRASG12C | KRASG12C-mutated locally advanced or metastatic colorectal cancer | sNDA (Priority) | 6/21/2024 | |
Merck & Co. Inc., of Kenilworth, N.J. | Keytruda (pembrolizumab) | Anti-PD-1 antibody | Primary advanced or recurrent endometrial carcinoma | sBLA (Priority) | 6/21/2024 | |
Sarepta Therapeutics Inc., of Cambridge, Mass. | Elevidys (delandistrogene moxeparvovec-rokl) | Single-dose, adeno-associated virus-based gene transfer therapy; intravenous infusion | Duchenne muscular dystrophy | sBLA (Priority) | 6/21/2024 | |
Harmony Biosciences Holdings Inc., of Plymouth Meeting, Pa. | Wakix (pitolisant) | Histamine 3 receptor antagonist/inverse agonist | Pediatric narcolepsy | sNDA | 6/21/2024 | |
Verona Pharma plc, of London | Ensifentrine | Inhibits PDE3/4 | Chronic obstructive pulmonary disease | NDA (Priority) | 6/26/2024 | |
Daiichi Sankyo Co. Ltd., of Basking Ridge, N.J., and Merck & Co. Inc., of Rahway, N.J. | HER3-DXd (patritumab deruxtecan) | HER3-directed antibody-drug conjugate | Locally advanced or metastatic EGFR-mutated non-small-cell lung cancer | BLA (Priority) | 6/26/2024 | |
Shorla Oncology, of Cambridge, Mass. | SH-105 | Freeze-dried powder form of a well-established drug | Breast and ovarian cancer | NDA | 6/29/2024 | |
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo | Enhertu (trastuzumab deruxtecan) | HER2-directed antibody-drug conjugate | Unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors | sBLA (Priority) | 6/29/2024 | *Q2:2024 |
Rocket Pharmaceuticals Inc., of Cranbury, N.J. | RP-L201 (marnetegragene autotemcel) | A lentiviral vector-based gene therapy | Leukocyte adhesion deficiency-1 | BLA (Priority) | 6/30/2024 | |
Genentech, part of Roche Group AG, of Basel, Switzerland | Crovalimab | Anti-C5 recycling monoclonal antibody | Paroxysmal nocturnal hemoglobinuria | BLA (Priority) | 7/6/2024 | * |
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. | Roflumilast cream 0.15% | Next-generation topical PDE4 inhibitor | Atopic dermatitis | sNDA | 7/7/2024 | |
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | Entyvio (vedolizumab) | Monoclonal antibody targeting alpha4beta7 integrin | Moderately to severely active Crohn’s disease | BLA | 7/13/2024 | * |
Orexo AB, of Uppsala, Sweden | OX-124 | Naloxone rescue medication; opioid receptor antagonist | Opioid overdose | NDA | 7/15/2024 | |
Phathom Pharmaceuticals Inc., of Florham Park, N.J. | Voquezna (vonoprazan) tablets | Potassium-competitive acid blocker | Erosive gastroesophageal reflux disease | NDA | 7/19/2024 | |
Xspray Pharma AB, of Stockholm | Dasynoc | Optimized version of dasatinib | Chronic myeloid leukemia | NDA | 7/31/2024 | |
Adaptimmune Therapeutics plc, of?Philadelphia, and Oxford, U.K. | Afami-cel | Engineered T-cell therapy | Advanced synovial sarcoma | BLA (Priority) | 8/4/2024 | |
Lykos Therapeutics Inc., of San Jose, Calif. | Midomafetamine capsules | MDMA-assisted therapy | Post-traumatic stress disorder | NDA (Priority) | 8/11/2024 | |
Citius Pharmaceuticals Inc., of Cranford, N.J. | Lymphir (denileukin diftitox) | IL-2-based immunotherapy | Relapsed or refractory cutaneous T-cell lymphoma | BLA | 8/13/2024 | |
Galderma SA, of Lausanne, Switzerland | Nemolizumab | Humanized monoclonal antibody directed against IL-31 receptor | Prurigo nodularis and moderate to severe atopic dermatitis | BLA (Priority) | 8/14/2024 | * |
Servier SAS, of Paris | Vorasidenib | Oral, brain-penetrant dual inhibitor of mutant IDH1 and IDH2 | IDH-mutant diffuse glioma | NDA (Priority) | 8/20/2024 | |
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | Linvoseltamab | BCMAxCD3 bispecific antibody | Relapsed/refractory multiple myeloma | BLA (Priority) | 8/22/2024 | |
Abbvie Inc., of North Chicago, and Genmab A/S, of Copenhagen, Denmark | Epkinly (epcoritamab) | IgG1-bispecific antibody binding to CD3 on T cells and CD20 on B cells | Relapsed or refractory follicular lymphoma | sBLA (Priority) | 8/27/2024 | * |
Incyte Corp., of Wilmington, Del. | Axatilimab | Anti-CSF-1R antibody | Chronic graft-vs.-host disease | BLA (Priority) | 8/28/2024 | |
Samsung Bioepis Co. Ltd., of Incheon, Korea, and Organon Co. and Ltd., of Jersey City, N.J. | Hadlima | Citrate-free, high-concentration, injection 40 mg/0.4 mL; biosimilar referencing Humira (adalimumab) | Interchangeability designation; moderate to severe plaque psoriasis | sBLA | 9/7/2024 | * |
Vanda Pharmaceuticals Inc., of Washington | Tradipitant | Neurokinin-1 receptor antagonist | Gastroparesis | NDA | 9/18/2024 | |
Zevra Therapeutics Inc., of Celebration, Fla. | Arimoclomol | Chaperonin stimulator; Hsp70 stimulator; orally delivered | Niemann-Pick disease type C | NDA | 9/21/2024 | |
Intrabio Inc., of Oxford, U.K. | IB-1001 | Orally administered therapy; N-acetyl-L-leucine | Niemann-Pick disease type C | NDA (Priority) | 9/24/2024 | |
Karuna Therapeutics Inc., of Boston | KarXT (xanomeline-trospium) | Muscarinic antipsychotic | Schizophrenia | NDA | 9/26/2024 | |
Syndax Pharmaceuticals Inc., of Waltham, Mass. | Revumenib | Inhibits the binding of menin to KMT2A | Relapsed or refractory KMT2Ar acute leukemia | NDA (Priority) | 9/26/2024 | |
Accord Biopharma Inc., of Durham, N.C. | DMB-3115 | Biosimilar Stelara (ustekinumab, Johnson & Johnson); IL-12 receptor antagonist; IL-23 antagonist | Autoimmune disease | BLA | 10/4/2024 | * |
Bristol Myers Squibb Co., of Princeton, N.J. | Opdivo (nivolumab) | PD-1 immune checkpoint inhibitor | Perioperative treatment of resectable stage IIa to IIIb non-small-cell lung cancer | sBLA | 10/8/2024 | |
Intercept Pharmaceuticals Inc., of Morristown, N.J. | Ocaliva (obeticholic acid) | Farnesoid X receptor agonist | Primary biliary cholangitis | sNDA | 10/15/2024 | |
Journey Medical Corp., of Scottsdale, Ariz. | DFD-29 (minocycline hydrochloride modified-release capsules) 40-mg | Targets bacterial 30S ribosomal subunit, inhibiting protein synthesis | Inflammatory lesions and erythema in adult patients with rosacea | NDA | 11/4/2024 | |
Applied Therapeutics Inc., of New York | AT-007 (govorestat) | Penetrant aldose reductase inhibitor | Classic galactosemia | NDA | 11/28/2024 | |
Bridgebio Pharma Inc., of Palo Alto, Calif. | Acoramidis | Next-generation, oral, small-molecule stabilizer of transthyretin | Transthyretin amyloid cardiomyopathy | NDA | 11/29/2024 | |
Shorla Oncology, of Cambridge, Mass. | SH-105 | Freeze-dried powder form of a well-established drug | Certain forms of leukemia and other cancers | NDA | 11/30/2024 | |
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo | Dato-Dxd (datopotamab deruxtecan) | Engineered TROP2-directed DXd antibody-drug conjugate | Locally advanced or metastatic nonsquamous non-small-cell lung cancer | BLA | 12/20/2024 | *Q4:2024 |
Beigene Ltd., of Basel, Switzerland, Beijing, and Cambridge, Mass. | Tevimbra (tislelizumab) | Humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fc?) receptors on macrophages | Locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma | BLA | 12/27/2024 | |
UCB SA, of Brussels, Belgium | Bimzelx (bimekizumab) | IL-17A and IL17F inhibitor | Psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis | sBLA | 12/28/2024 | * |
Xcovery Holdings Inc., of Palm Beach Gardens, Fla. | Ensartinib | ALK inhibitor | ALK-positive non-small-cell lung-cancer | NDA | 12/28/2024 | |
Pfizer Inc., of New York | Marstacimab (PF-06741086) | Anti-tissue factor pathway inhibitor | Hemophilia A or B | BLA | 12/31/2024 | *Q4:2024 |
Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo | Dato-Dxd (datopotamab deruxtecan) | Engineered TROP2-directed Dxd antibody-drug conjugate | Unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer | BLA | 1/29/2025 | |
UCB SA, of Brussels, Belgium | Bimzelx (bimekizumab) | IL-17A and IL17F inhibitor | Moderate to severe hidradenitis suppurativa | sBLA | 2/3/2025 | * |
Stealth Biotherapeutics Corp., of Boston | Elamipretide | Small mitochondrially targeted tetrapeptide | Barth syndrome | NDA | 2/8/2025 |