January | February | March | April | May |
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Drug | Description | FDA approved use | Company | FDA filing | Pathway | Date |
Balversa (erdafitinib) | Once-daily, oral FGFR kinase inhibitor | Locally advanced or metastatic urothelial carcinoma | Janssen Pharmaceutical Cos., of Johnson & Johnson, of New Brunswick, N.J. | sNDA | N/A | 1/19/2024 |
Casgevy (exagamglogene autotemcel) | CRISPR/Cas9 gene-edited therapy | Transfusion-dependent beta thalassemia | Vertex Pharmaceuticals Inc., of Boston, and Crispr Therapeutics, of Zug, Switzerland | BLA | Standard | 1/16/2024 |
Dupixent (dupilumab) | Fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways | Eosinophilic esophagitis | Sanofi AG, of Paris | sBLA | Priority | 1/25/2024 |
Gammagard | Immune globulin infusion (human) 10% solution; intravenous immunoglobulin (IVIG) therapy | Chronic inflammatory demyelinating polyneuropathy | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Halozyme Therapeutics Inc., of San Diego | sNDA | N/A | 1/30/2024 |
Keytruda (pembrolizumab) | Anti-PD-1 therapy | High-risk locally advanced cervical cancer | Merck & Co. Inc., of Rahway, N.J. | sBLA | Priority | 1/12/2024 |
Welireg (belzutifan) | Small-molecule inhibitor of hypoxia-inducible factor (HIF)-2a | Advanced renal cell carcinoma | Merck & Co. Inc., of Kenilworth, N.J. | sNDA | Priority | 1/14/2024 |
Zelsuvmi | Berdazimer topical gel, 10.3% | Molluscum contagiosum (molluscum) | Ligand Pharmaceuticals Inc., of San Diego | NDA | NME;Standard | 1/5/2024 |
Zynrelef | Extended-release solution of bupivacaine and meloxicam | Soft tissue and orthopedic surgical procedures | Heron Therapeutics Inc., of San Diego | sNDA | N/A | 1/23/2024 |
Aurlumyn (iloprost) | Injectable vasodilator | Severe frostbite | Eicos Sciences Inc., of San Mateo, Calif. | NDA | Priority; orphan | 2/13/2024 |
Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) | HIV-1 integrase inhibitor; nucleoside reverse transcriptase inhibitor | HIV infection | Gilead Sciences Inc., of Foster City, Calif. | sNDA | N/A | 2/23/2024 |
Eohilia (budesonide oral suspension) | Glucocorticoid receptor agonist | Eosinophilic esophagitis | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | NDA | Priority; orphan | 2/9/2024 |
Exblifep (cefepime/enmetazobactam) | Beta-lactam/beta-lactamase inhibitor (BL/BLI) combination | Complicated urinary tract infections, including pyelonephritis | Allecra Therapeutics GmbH, of Saint-Louis, France, and Weill am Rhein, Germany | NDA | NME;Priority | 2/22/2024 |
Letybo/letibotulinumtoxinA-wlbg | Purified neurotoxin complex derived from the bacterium Clostridium botulinum | Moderate to severe glabellar lines | Hugel America Inc., of Newport Beach, Calif. | BLA | NME | 2/29/2024 |
Lifileucel | Autologous tumor-infiltrating lymphocyte cell therapy | Advanced melanoma | Iovance Biotherapeutics Inc., of San Carlos, Calif. | BLA | Priority; accelerated | 2/20/2024 |
Onivyde | Liposomal injection of irinotecan | Metastatic pancreatic ductal adenocarcinoma | Ipsen SA, of Paris | sNDA | N/A | 2/13/2024 |
Simlandi (adalimumab-ryvk) | Interchangeable biosimilar to Humira (adalimumab, Abbvie Inc.) | Rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis | Alvotech Holding SA, of Reykjavik, Iceland, and Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel | BLA | N/A | 2/23/2024 |
Tagrisso (osimertinib) | Third-generation, irreversible EGFR tyrosine kinase inhibitor | Locally advanced or metastatic EGFRm non-small-cell lung cancer | Astrazeneca plc, of London | sNDA | N/A | 2/19/2024 |
Tecvayli (teclistamab) | Fully humanized, T-cell redirecting IgG4 bispecific antibody targeting both BCMA and CD3 | Relapsed and refractory multiple myeloma | Janssen Research & Development LLC, part of Johnson & Johnson, of New Brunswick, N.J. | sBLA | N/A | 2/20/2024 |
Xolair (omalizumab) | Antibody designed to target and block IgE | Reduction of allergic reactions | Genentech, a unit of Roche AG, of Basel, Switzerland | sBLA | N/A | 2/16/2024 |
Acthar Gel (repository corticotropin injection) | Melanocortin receptor agonist; adrenocorticotrophic hormone ligand | Chronic and acute inflammatory and autoimmune conditions | Mallinckrodt plc, of Dublin | sNDA | N/A | 3/1/2024 |
Besponsa (inotuzumab ozogamicin) | CD22-directed antibody-drug conjugate | Relapsed or refractory CD22-positive B-cell precursor lymphoblastic leukemia | Pfizer Inc., of New York | sBLA | N/A | 3/6/2024 |
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 | Bristol Myers Squib Co., of Princeton, N.J. | sBLA | Priority; accelerated | 3/14/2024 |
Brukinsa (zanubrutinib) | Small-molecule inhibitor of Bruton's tyrosine kinase | Relapsed or refractory follicular lymphoma | Beigene Ltd., of Basel, Switzerland, Beijing, and Cambridge, Mass. | sNDA | Accelerated | 3/7/2024 |
Clobetasol propionate ophthalmic suspension 0.05% (APP-13007) | Ophthalmic nanosuspension formulation of a clobetasol propionate (0.05%) | Inflammation and pain after ocular surgery | Formosa Inc., of Cambridge, Mass., and Aimmax Therapeutics Inc., of Durham, N.C. | NDA | Priority | 3/4/2024 |
Duvyzat (givinostat) | HDAC inhibitor | Duchenne muscular dystrophy | Italfarmaco Group, of Milan, Italy | NDA | NME;Priority; fast track; orphan; rare pediatric disease | 3/21/2024 |
Edurant Ped (rilpivirine) | Human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) | HIV-1 infection | Johnson & Johnson, of New Brunswick, N.J. | NDA | Priority | 3/15/2024 |
Elahere (mirvetuximab soravtansine-gynx) | Antibody-drug conjugate comprising a folate receptor alpha-binding antibody, cleavable linker and the maytansinoid payload DM4 | Ovarian cancer | Abbvie Inc., of North Chicago | sBLA | N/A | 3/22/2024 |
Iclusig (ponatinib) | Kinase inhibitor targeting BCR-ABL1 | Philadelphia chromosome-positive acute lymphoblastic leukemia | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | sNDA | N/A | 3/19/2024 |
Ixinity (trenonacog alfa) | Intravenous recombinant factor IX | Hemophilia B | Medexus Pharmaceuticals Inc., of Toronto | sBLA | N/A | 3/26/2024 |
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 | Orchard Therapeutics Inc., of Boston and London | BLA | Priority | 3/18/2024 |
Livmarli (maralixibat) | Ileal bile acid transporter inhibitor | Progressive familial intrahepatic cholestasis | Mirum Pharmaceuticals Inc., of Foster City, Calif. | sNDA | N/A | 3/13/2024 |
Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe) tablets | ATP citrate lyase inhibitors | Cardiovascular risk reduction and expanded LDL-C lowering | Esperion Therapeutics Inc., of Ann Arbor, Mich. | sNDA | N/A | 3/22/2024 |
Opdivo (nivolumab) | Fully human immunoglobulin G4 PD-1 immune checkpoint inhibitor antibody | Unresectable or metastatic urothelial carcinoma | Bristol Myers Squibb Co., of Princeton, N.J. | sBLA | Priority | 3/6/2024 |
Opsynvi (macitentan and tadalafil) | Single-tablet combination of endothelin receptor antagonist and PDE5 inhibitor | Pulmonary arterial hypertension | Johnson & Johnson, of Raritan, N.J. | NDA | Standard; orphan | 3/22/2024 |
Praluent (alirocumab) | PCSK9 inhibitor | Heterozygous familial hypercholesterolemia (HeFH) | Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | N/A | 3/8/2024 |
Rezdiffra (Resmetirom) | Liver-directed THR-beta agonist | Nonalcoholic steatohepatitis with liver fibrosis | Madrigal Pharmaceuticals Inc., of Conshohocken, Pa. | NDA | NME; Priority | 3/14/2024 |
Rybrevant (amivantamab-vmjw) and lazertinib | Fully human bispecific antibody targeting EGFR and MET; oral, third-generation, brain penetrant EGFR tyrosine kinase inhibitor | Locally advanced or metastatic non-small-cell lung cancer with EGFR exon 19 deletions or L858R substitution mutations | Johnson & Johnson, of Raritan, N.J. | sBLA | N/A | 3/1/2024 |
Spevigo (spesolimab) | Humanized, selective antibody that blocks the activation of the interleukin-36 receptor | Generalized pustular psoriasis | Boehringer Ingelheim GmbH, of Ingelheim, Germany | sBLA | N/A | 3/18/2024 |
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 | Beigene Ltd., of Basel, Switzerland, Beijing, and Cambridge, Mass. | BLA | Orphan | 3/13/2024 |
Tryvio (aprocitentan) | Dual endothelin receptor antagonist | Hypertension | Idorsia Pharmaceuticals Ltd., of Allschwil, Switzerland | NDA | NME; standard | 3/19/2024 |
Tyenne (tocilizumab-aazg) | Biosimilar referencing tocilizumab | Multiple autoimmune diseases | Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA, of Bad Homburg, Germany | BLA | N/A | 3/7/2024 |
Ultomiris (ravulizumab) | Long-acting C5 complement inhibitor | Neuromyelitis optica spectrum disorder | Astrazeneca plc, of Cambridge, U.K. | sBLA | N/A | 3/25/2024 |
Vafseo (vadadustat) tablets | Oral hypoxia-inducible factor prolyl hydroxylase inhibitor | Anemia due to chronic kidney disease | Akebia Therapeutics Inc., of Cambridge, Mass. | NDA | NME; standard | 3/27/2024 |
Vemlidy (tenofovir alafenamide 25 mg) | Prodrug of tenofovir | Chronic hepatitis B virus infection | Gilead Sciences Inc., of Foster City, Calif. | sNDA | N/A | 3/28/2024 |
Voydeya (danicopan) | Oral factor D inhibitor | Paroxysmal nocturnal hemoglobinuria | Astrazeneca plc, of Cambridge, U.K. | NDA | NME;Breakthrough;Orphan;Standard | 3/29/2024 |
Wegovy (semaglutide) | GLP-1 receptor agonist | To reduce the risk of major cardiovascular events in obese/overweight adults | Novo Nordisk A/S, of Bagsvaerd, Denmark | sNDA | N/A | 3/8/2024 |
Winrevair (sotatercept-csrk) | Activin signaling inhibitor | Pulmonary arterial hypertension | Merck & Co. Inc., of Rahway, N.J. | BLA | Priority;Breakthrough;NME | 3/26/2024 |
Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) | Interchangeables with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts | Hypercalcemia of malignancy refractory to bisphosphonate therapy; postmenopausal women with osteoporosis | Sandoz Inc., of Basel, Switzerland | BLA | N/A | 3/5/2024 |
Xhance | Fluticasone propionate nasal spray; drug-device combination product | Chronic sinusitis | Optinose Inc., of Yardley, Pa. | sNDA | N/A | 3/15/2024 |
Alecensa (alectinib) | Oral ALK inhibitor | ALK-positive early-stage resected non-small-cell lung cancer | Genentech Inc., of South San Francisco, a unit of Roche Holding AG | sNDA | N/A | 4/18/2024 |
Anktiva (nogapendekin alfa inbakicept) | IL-15 superagonist | Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma | Immunitybio Inc., of Culver City, Calif. | BLA | NME | 4/22/2024 |
Beqvez (fidanacogene elaparvovec) | Adeno-associated viral vector-based gene therapy | Hemophilia B | Pfizer Inc., of New York | BLA | Breakthrough; Regenerative Medicines Advanced Therapy; orphan | 4/26/2024 |
Biktarvy | Bictegravir 50 mg, emtricitabine 200 mg, tenofovir alafenamide 25 mg tablets | Pregnant people with HIV-1 (PWH) with suppressed viral load | Gilead Sciences Inc., of Foster City, Calif. | sNDA | N/A | 4/24/2024 |
Carvykti (ciltacabtagene autoleucel) | CAR T therapy targeting B-cell maturation antigen | Relapsed and lenalidomide-refractory multiple myeloma | Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson, and Legend Biotech Corp., of Somerset, N.J. | sBLA | N/A | 4/5/2024 |
Cyltezo (adalimumab) | Pen autoinjector; biosimilar to Humira (Abbvie Inc.) | Multiple chronic inflammatory diseases | Boehringer Ingelheim GmbH, of Ingelheim, Germany | sBLA | N/A | 4/30/2024 |
Dovato (dolutegravir/lamivudine) | 2-drug antiviral regimen | HIV infection | Viiv Healthcare Ltd., of London | sNDA | N/A | 4/5/2024 |
Enhertu (trastuzumab deruxtecan) | HER2-directed antibody-drug conjugate | HER2-expressing (IHC 3+) metastatic cancers | Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo | sBLA | N/A | 4/6/2024 |
Entyvio (vedolizumab) | Subcutaneous administration; single-dose prefilled pen; inhibits alpha4beta7 integrin | Moderately to severely active ulcerative colitis | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Cambridge, Mass. | sNDA | N/A | 4/18/2024 |
Fanapt (iloperidone) | Atypical antipsychotic agent | Manic or mixed episodes associated with bipolar I disorder | Vanda Pharmaceuticals Inc., of Washington | sNDA | N/A | 4/2/2024 |
Fasenra (benralizumab) | Monoclonal antibody targeting IL-5 receptor alpha | Severe eosinophilic asthma | Astrazeneca plc, of Cambridge, U.K. | sBLA | N/A | 4/11/2024 |
Hercessi (trastuzumab) | Biosimilar to Herceptin (trastuzumab, Roche AG) | HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma | Accord Biopharma Inc., of Durham, N.C. | BLA | N/A | 4/25/2024 |
Ingrezza Sprinkle (valbenazine) | VMAT2 inhibitor; oral granules; sprinkle formulation | Tardive dyskinesia | Neurocrine Biosciences Inc., of San Diego | NDA | Standard | 4/30/2024 |
Libervant | Buccal film formulation of diazepam | Intermittent, stereotypic episodes of frequent seizure activity | Aquestive Therapeutics Inc., of Warren, N.J. | NDA | Standard | 4/26/2024 |
Lumisight (pegulicianine) | Imaging agent | Residual breast cancer | Lumicell Inc., of Newton, Mass. | NDA | NME; Priority | 4/18/2024 |
Lupkynis (voclosporin) | Second-generation calcineurin inhibitor | Lupus nephritis | Aurinia Pharmaceuticals Inc., of Rockville, Md. | sNDA | N/A | 4/29/2024 |
Lutathera ([177Lu] oxodotreotide) | Radioligand therapy | Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors | Novartis AG, of Basel, Switzerland | sNDA | N/A | 4/23/2024 |
Naloxone Hcl | Nasal spray (4 mg) | Emergency treatment of an opioid overdose | Amneal Pharmaceuticals Inc., of Bridgewater, N.J. | ANDA | N/A | 4/24/2024 |
Ojemda (tovorafenib, DAY-101) | Oral, brain-penetrant, highly selective type II RAF kinase inhibitor | Relapsed or progressive pediatric low-grade glioma | Day One Biopharmaceuticals, of Brisbane, Calif. | NDA | Priority; rare pediatric disease; accelerated; NME | 4/23/2024 |
Pivya (pivmecillinam) | Oral prodrug of mecillinam | Uncomplicated urinary tract infection | Utility Therapeutics Ltd., of London | NDA | Priority | 4/24/2024 |
Selarsdi (ustekinumab-aekn) | Biosimilar to Stelara (ustekinumab) | Moderate to severe plaque psoriasis and for active psoriatic arthritis | Alvotech Holding SA, of Reykjavik, Iceland, and Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel | BLA | N/A | 4/16/2024 |
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 | Genmab A/S, of Copenhagen, Denmark, and Pfizer Inc., of New York | sBLA | Priority | 4/29/2024 |
Tranexamic acid in 0.7% sodium chloride | Intravenous antifibrinolytics | Short-term use in hemophilia | Nexus Pharmaceuticals Inc., of Lincolnshire, Ill. | ANDA | Standard | 4/16/2024 |
Xcopri (cenobamate) | Positive allosteric modulator of the ?-aminobutyric acid (GABAA) ion channel | Partial-onset (focal) seizures | SK Life Science Inc., of Paramus, N.J. | sNDA | N/A | 4/11/2024 |
Xolremdi (mavorixafor) | Small-molecule antagonist of the CXCR4 receptor | WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome | X4 Pharmaceuticals Inc., of Boston | NDA | Priority; NME | 4/26/2024 |
Zevtera (ceftobiprole medocaril sodium for injection) | Antibiotic | Staphylococcus aureus bacteremia, including right-sided infective endocarditis, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia | Basilea Pharmaceutica Ltd., of Allschwil, Switzerland | NDA | NME; Priority; Fast Track; Qualified Infectious Disease Product | 4/3/2024 |