| 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 |
| Bristol Myers Squibb Co., of Princeton, N.J., and 2seventy Bio Inc., of Cambridge, Mass. | Abecma (idecabtagene vicleucel) | Anti-BCMA CAR T-cell therapy | Relapsed and refractory multiple myeloma | sBLA | 12/16/2023 | *U.S. FDA Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental BLA; date of the ODAC meeting has not yet been confirmed by the FDA; FDA also informed the companies that a decision on the application will not be made by PDUFA target action date of Dec. 16, 2023 |
| Defender Pharmaceuticals Inc., of St. Louis | Scopolamine gel (DPI-386 nasal gel) | Antidepressant; anti-emetic; unspecified drug target | Prevention of nausea and vomiting induced by motion | NDA (Priority) | 1/26/2024 | |
| Vyluma Inc., of Bridgewater, N.J. | NVK-002 | Low-dose atropine (0.01%) | Myopia | NDA | 1/31/2024 | |
| Sanofi AG., of Paris | Dupixent (dupilumab) | Fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways | Eosinophilic esophagitis | sBLA (Priority) | 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 | * |
| Sandoz Inc., of Basel, Switzerland | Denosumab | Human monoclonal antibody designed to bind to the RANKL protein | Osteoporosis in postmenopausal women | BLA | 2/6/2024 | * |
| Merck & Co. Inc., of Rahway, N.J. | Keytruda (pembrolizumab) | Anti-PD-1 therapy | Locally advanced unresectable or metastatic biliary tract cancer | sBLA | 2/7/2024 | |
| Ipsen SA, of Paris | Onivyde | Liposomal injection of irinotecan | Metastatic pancreatic ductal adenocarcinoma | sNDA | 2/13/2024 | |
| Venatorx Pharmaceuticals Inc., of Malvern, Pa. | Cefepime-taniborbactam | Beta-lactam/beta-lactamase inhibitor | Complicated urinary tract infections | NDA | 2/22/2024 | |
| Iovance Biotherapeutics Inc., of San Carlos, Calif. | Lifileucel | Autologous tumor-infiltrating lymphocyte cell therapy | Advanced melanoma | BLA (Priority) | 2/24/2024 | |
| Minerva Neurosciences Inc., of Burlington, Mass. | Roluperidone | Dual 5-HT2A/sigma 2 antagonist | Negative symptoms in schizophrenia | NDA (Standard) | 2/26/2024 | |
| Formosa Inc., of Cambridge, Mass., and Aimmax Therapeutics Inc., of Durham, N.C. | APP-13007 | Ophthalmic nanosuspension formulation of a clobetasol propionate (0.05%) | Inflammation and pain after ocular surgery | NDA | 3/4/2024 | |
| Viatris Inc., of Canonsburg, Penn., and Mapi Pharma Ltd., of Ness Ziona, Israel | Glatiramer acetate | Long-acting; 40-mg dose | Relapsing forms of multiple sclerosis | NDA | 3/8/2024 | |
| Mirum Pharmaceuticals Inc., of Foster City, Calif. | Livmarli (maralixibat) | Ileal bile acid transporter inhibitor | Progressive familial intrahepatic cholestasis | N/A | 3/13/2024 | |
| Madrigal Pharmaceuticals Inc., of Conshohocken, Pa. | Resmetirom | Liver-directed THR-beta agonist | Nonalcoholic steatohepatitis with liver fibrosis | NDA (Priority) | 3/14/2024 | |
| Bristol Myers Squib Co., of Princeton, N.J. | Breyanzi (lisocabtagene maraleucel) | CD19-directed CAR T-cell therapy with a 4-1BB costimulatory domain | Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after treatment with a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor | sBLA | 3/14/2024 | |
| Optinose Inc., of Yardley, Pa. | Xhance | Fluticasone propionate nasal spray; drug-device combination product | Chronic sinusitis | sNDA | 3/16/2024 | |
| Orchard Therapeutics Inc., of Boston and London | Libmeldy (atidarsagene autotemcel, OTL-200) | Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene | Metachromatic leukodystrophy | BLA (Priority) | 3/18/2024 | |
| Italfarmaco Group, of Milan, Italy | Givinostat | HDAC inhibitor | Duchenne muscular dystrophy | NDA | 3/21/2024 | |
| Merck & Co. Inc., of Rahway, N.J. | Sotatercept | Activin signaling inhibitor | Pulmonary arterial hypertension | BLA (Priority) | 3/26/2024 | |
| Akebia Therapeutics Inc., of Cambridge, Mass. | Vadadustat | Oral hypoxia-inducible factor prolyl hydroxylase inhibitor | Anemia due to chronic kidney disease | NDA | 3/27/2024 | |
| Beigene Ltd., of Beijing | Brukinsa (zanubrutinib) | BTK inhibitor | Follicular lymphoma | sNDA | 3/31/2024 | *Q1:2024 |
| Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | Odronextamab | Bispecific antibody targeting CD20 and CD3 | Third-line or later relapsed/refractory (R/R) follicular lymphoma and R/R diffuse large B-cell lymphoma | BLA (Priority) | 3/31/2024 | |
| Rocket Pharmaceuticals Inc., of Cranbury, N.J. | RP-L201 (marnetegragene autotemcel) | A lentiviral vector-based gene therapy | Leukocyte adhesion deficiency-1 | BLA (Priority) | 3/31/2024 | |
| Astrazeneca plc, of London | Flumist Quadrivalent | Protein-based vaccine | Influenza prophylaxis | sBLA | 3/31/2024 | * |
| Genentech, a unit of Roche AG, of Basel, Switzerland | Xolair (omalizumab) | Antibody designed to target and block IgE | Reduction of allergic reactions | BLA (Priority) | 3/31/2024 | * |
| Basilea Pharmaceutica Ltd., of Allschwil, Switzerland | Ceftobiprole | Antibiotic | Staphylococcus aureus bacteremia, including right-sided infective endocarditis, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia | NDA | 4/3/2024 | |
| X4 Pharmaceuticals Inc., of Boston | Oral mavorixafor | Small-molecule antagonist of the CXCR4 receptor | WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome | NDA | 4/3/2024 | |
| Supernus Pharmaceuticals Inc., of Rockville, Md. | SPN-830 | Apomorphine infusion device | Motor fluctuations in Parkinson’s disease | NDA | 4/5/2024 | |
| Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson, and Legend Biotech Corp., of Somerset, N.J. | Carvykti (ciltacabtagene autoleucel) | CAR T therapy targeting B-cell maturation antigen | Relapsed and lenalidomide-refractory multiple myeloma | sBLA | 4/5/2024 | |
| Bristol Myers Squibb Co., of Princeton, N.J. | Opdivo (nivolumab) | PD-1 immune checkpoint inhibitor | Unresectable or metastatic urothelial carcinoma | sBLA (Priority) | 4/5/2024 | |
| Immunogen Inc., of Waltham, Mass. | Elahere (mirvetuximab soravtansine-gynx) | ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4 | Folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer | sBLA (Accelerated; Priority) | 4/5/2024 | |
| Medexus Pharmaceuticals Inc., of Montreal | Ixinity (trenonacog alfa) | Intravenous recombinant factor IX | Hemophilia B | sBLA | 4/15/2024 | * |
| Astrazeneca plc, of London | Tagrisso (osimertinib | Third-generation, irreversible EGFR-TKI | Non-small-cell lung cancer (NSCLC) | sNDA (Priority) | 4/16/2024 | * |
| 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 | 4/24/2024 | |
| Pfizer Inc., of New York | Fidanacogene elaparvovec | Gene therapy | Hemophilia B | BLA (Breakthrough; Regenerative Medicines Advanced Therapy; orphan) | 4/27/2024 | * |
| 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 | 4/29/2024 | |
| 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 | 4/30/2024 | *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 | |
| 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 | |
| Boehringer Ingelheim GmbH, of Germany | Ofev (nintedanib) | Small-molecule tyrosine kinase inhibitor | Fibrosing interstitial lung disease | sNDA | 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 | |
| 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 | 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 | 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 | * |
| 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 | |
| Zevra Therapeutics Inc., of Celebration, Fla. | Arimoclomol | Chaperonin stimulator; Hsp70 stimulator; orally delivered | Niemann-Pick disease type C | NDA | 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 | |
| Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | TAK-721 (budesonide oral suspension) | Glucocorticoid receptor agonist | Eosinophilic esophagitis | NDA (Priority) | 6/30/2024 | * |
| Genentech, part of Roche Group AG, of Basel, Switzerland | Crovalimab | Anti-C5 recycling monoclonal antibody | Paroxysmal nocturnal hemoglobinuria | BLA | 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 | |
| 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 | Unresectable, locally advanced or metastatic esophageal squamous cell carcinoma | BLA | 7/19/2024 | * |
| Phathom Pharmaceuticals Inc., of Florham Park, N.J. | Voquezna (vonoprazan) tablets | Potassium-competitive acid blocker | Erosive gastroesophageal reflux disease | NDA | 7/19/2024 | |
| 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 | |
| Karuna Therapeutics Inc., of Boston | KarXT (xanomeline-trospium) | Muscarinic antipsychotic | Schizophrenia | NDA | 9/26/2024 | |
| Arcutis Biotherapeutics Inc., of Westlake Village, Calif. | Roflumilast | Topical PDE4 inhibitor | Atopic dermatitis | sNDA | 9/30/2024 | * |
| 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 | * |
| Pfizer Inc., of New York | Marstacimab (PF-06741086) | Anti-tissue factor pathway inhibitor | Hemophilia A or B | BLA | 12/31/2024 | *Q4:2024 |