New Indications & Dosage Forms for Existing Drugs
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
Gamifant (emapalumab-lzsg) Injection
New Indication Approved: June 28, 2025
Date of Original Approval: November 20, 2018
Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody for the treatment of primary hemophagocytic lymphohistiocytosis and macrophage activation syndrome in Still’s disease.
Gammagard Liquid (immune globulin infusion (human)) Solution
New Formulation Approved: June 27, 2025
Date of Original Approval: April 27, 2005
Gammagard Liquid (immune globulin infusion (human)) is an immune globulin therapy for use in the treatment of primary humoral immunodeficiency, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy.
Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion
Labeling Revision Approved: June 26, 2025
Date of Original Approval: February 5, 2021
Breyanzi (lisocabtagene maraleucel) is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma.
Datroway (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection
New Indication Approved: June 23, 2025
Date of Original Approval: January 17, 2025
Datroway (datopotamab deruxtecan-dlnk) is a TROP2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.
Vizamyl (flutemetamol F 18) Injection
Labeling Revision Approved: June 23, 2025
Date of Original Approval: October 25, 2013
Vizamyl (flutemetamol F 18) is a PET amyloid imaging agent for the evaluation of Alzheimer's disease and other cognitive disorders.
Benlysta (belimumab) Injection
New Dosage Regimen: June 20, 2025
Date of Original Approval: March 10, 2011
Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor for the treatment of active systemic lupus erythematosus (SLE) and active lupus nephritis.
Dupixent (dupilumab) Injection
New Indication Approved: June 18, 2025
Date of Original Approval: March 28, 2017
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria, and bullous pemphigoid.
Monjuvi (tafasitamab-cxix) for Injection
New Indication Approved: June 18, 2025
Date of Original Approval: July 31, 2020
Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody used in the treatment of diffuse large B-cell lymphoma and follicular lymphoma.
Endari (L-glutamine) Oral Powder
Labeling Revision Approved: June 18, 2025
Date of Original Approval: July 7, 2017
Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.
mRESVIA (respiratory syncytial virus vaccine, mRNA) Injection
Patient Population Altered: June 12, 2025
Date of Original Approval: May 31, 2024
mRESVIA is a modified RNA vaccine for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
Keytruda (pembrolizumab) for Injection
New Indication Approved: June 12, 2025
Date of Original Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody used to treat multiple types of cancer.
Steqeyma (ustekinumab-stba) Injection
New Dosage Form Approved: June 12, 2025
Date of Original Approval: December 17, 2024
Steqeyma (ustekinumab-stba) is a human interleukin-12 and -23 antagonist interchangeable biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Mavyret (glecaprevir and pibrentasvir) Tablets and Oral Pellets
New Indication Approved: June 10, 2025
Date of Original Approval: August 3, 2017
Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, used for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.
Brukinsa (zanubrutinib) Capsules and Tablets
New Dosage Form Approved: June 10, 2025
Date of Original Approval: November 14, 2019
Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor used for the treatment of mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma.
Nubeqa (darolutamide) Tablets
New Indication Approved: June 3, 2025
Date of Original Approval: July 30, 2019
Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) used in the treatment of prostate cancer.
Xenoview (xenon Xe 129 hyperpolarized) for Oral Inhalation
Patient Population Altered: May 30, 2025
Date of Original Approval: December 23, 2022
Xenoview (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older.
Nucala (mepolizumab) Injection
New Indication Approved: May 22, 2025
Date of Original Approval: November 4, 2015
Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) used for the treatment of with severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
Zoryve (roflumilast) Cream and Foam
New Indication Approved: May 22, 2025
Date of Original Approval: July 29, 2022
Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of plaque psoriasis (0.3% cream, 0.3% foam), atopic dermatitis (0.15% cream) and seborrheic dermatitis (0.3% foam).
Susvimo (ranibizumab) Injection for Intravitreal Use via Ocular Implant
New Indication Approved: May 21, 2025
Date of Original Approval: October 25, 2021
Susvimo (ranibizumab) is a vascular endothelial growth factor (VEGF) inhibitor used for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
Yuflyma (adalimumab-aaty) Injection
Labeling Revision Approved: May 21, 2025
Date of Original Approval: May 23, 2023
Yuflyma (adalimumab-aaty) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Hadlima (adalimumab-bwwd) Injection
Labeling Revision Approved: May 21, 2025
Date of Original Approval: July 23, 2019
Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Jivi (antihemophilic factor [recombinant] PEGylated-aucl) Injection
Patient Population Altered: May 19, 2025
Date of Original Approval: August 30, 2018
Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, factor VIII concentrate used to treat and control bleeding in patients with hemophilia A.
Zynyz (retifanlimab-dlwr) Injection
New Indication Approved: May 15, 2025
Date of Original Approval: March 22, 2023
Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody used for the treatment of advanced anal cancer and Merkel cell carcinoma.
Welireg (belzutifan) Tablets
New Indication Approved: May 14, 2025
Date of Original Approval: August 13, 2021
Welireg (belzutifan) is a selective inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α) for the treatment of von Hippel-Lindau (VHL) disease, advanced renal cell carcinoma, and pheochromocytoma or paraganglioma (PPGL).
Selarsdi (ustekinumab-aekn) Injection
Labeling Revision Approved: April 30, 2025
Date of Original Approval: April 16, 2024
Selarsdi (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist interchangeable biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Otulfi (ustekinumab-aauz) Injection
Labeling Revision Approved: April 30, 2025
Date of Original Approval: September 27, 2024
Otulfi (ustekinumab-aauz) is a human interleukin-12 and -23 antagonist interchangeable biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Rinvoq (upadacitinib) Extended-Release Tablets
New Indication Approved: April 28, 2025
Date of Original Approval: August 16, 2019
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.
Camzyos (mavacamten) Capsules
Labeling Revision Approved: April 17, 2025
Date of Original Approval: April 28, 2022
Camzyos (mavacamten) is a first-in-class cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
Dupixent (dupilumab) Injection
New Indication Approved: April 17, 2025
Date of Original Approval: March 28, 2017
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria, and bullous pemphigoid.
Valtoco (diazepam) Nasal Spray
Patient Population Altered: April 16, 2025
Date of Original Approval: January 10, 2020
Valtoco (diazepam) is an immediate-use benzodiazepine nasal spray for the short-term treatment of seizure clusters in patients with epilepsy.
Isturisa (osilodrostat) Tablets
New Indication Approved: April 15, 2025
Date of Original Approval: March 6, 2020
Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Livmarli (maralixibat) Oral Solution and Tablets
New Formulation Approved: April 14, 2025
Date of Original Approval: September 29, 2021
Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor used for the treatment of cholestatic pruritus in patients with Alagille syndrome or progressive familial intrahepatic cholestasis.
Opdivo (nivolumab) Injection
New Indication Approved: April 11, 2025
Date of Original Approval: December 22, 2014
Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection
New Dosage Form Approved: April 10, 2025
Date of Original Approval: June 20, 2023
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is a neonatal Fc receptor blocker and endoglycosidase combination used for the treatment of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Vitrakvi (larotrectinib) Capsules and Oral Solution
Labeling Revision Approved: April 9, 2025
Date of Original Approval: November 26, 2018
Vitrakvi (larotrectinib) is a tropomyosin receptor kinase inhibitor used for the treatment of solid tumors.
Opdivo (nivolumab) Injection
New Indication Approved: April 8, 2025
Date of Original Approval: December 22, 2014
Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.
Yuflyma (adalimumab-aaty) Injection
Labeling Revision Approved: April 7, 2025
Date of Original Approval: May 23, 2023
Yuflyma (adalimumab-aaty) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Uplizna (inebilizumab-cdon) Injection
New Indication Approved: April 3, 2025
Date of Original Approval: June 11, 2020
Uplizna (inebilizumab-cdon) is a CD19-directed cytolytic antibody used for the treatment of neuromyelitis optica spectrum disorder and immunoglobulin G4-related disease.
Tryvio (aprocitentan) Tablets
Labeling Revision Approved: April 2, 2025
Date of Original Approval: March 19, 2024
Tryvio (aprocitentan) is an endothelin receptor antagonist (ERA) for the combination treatment of hypertension that is not adequately controlled with other drugs.
Jynneos (smallpox and mpox vaccine) Injection
New Formulation Approved: March 31, 2025
Date of Original Approval: September 24, 2019
Jynneos (smallpox and mpox vaccine, live, non-replicating) is a vaccine for the prevention of smallpox and mpox disease.
Pluvicto (lutetium lu 177 vipivotide tetraxetan) Injection
New Indication Approved: March 28, 2025
Date of Original Approval: March 23, 2022
Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent for use in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Imfinzi (durvalumab) Injection
New Indication Approved: March 28, 2025
Date of Original Approval: May 1, 2017
Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody used for the treatment of non-small cell lung cancer, small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, endometrial cancer, and bladder cancer.
Cabometyx (cabozantinib) Tablets
New Indication Approved: March 26, 2025
Date of Original Approval: April 25, 2016
Cabometyx (cabozantinib) is a tyrosine kinase inhibitor used for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, differentiated thyroid cancer, and neuroendocrine tumors.
Egrifta WR (tesamorelin) Injection
New Formulation Approved: March 25, 2025
Date of Original Approval: November 10, 2010
Egrifta WR (tesamorelin) is a synthetic analogue of growth hormone releasing factor (GRF) for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Amvuttra (vutrisiran) Injection
New Indication Approved: March 20, 2025
Date of Original Approval: June 13, 2022
Amvuttra (vutrisiran) is an RNAi therapeutic for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis and cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis.
Fabhalta (iptacopan) Capsules
New Indication Approved: March 20, 2025
Date of Original Approval: December 5, 2023
Fabhalta (iptacopan) is a complement factor B inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy.
Tremfya (guselkumab) Injection
New Indication Approved: March 20, 2025
Date of Original Approval: July 13, 2017
Tremfya (guselkumab) is an interleukin-23 blocker for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
Keytruda (pembrolizumab) for Injection
Labeling Revision Approved: March 19, 2025
Date of Original Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody used to treat multiple types of cancer.
Gvoke (glucagon) Injection
New Indication Approved: March 14, 2025
Date of Original Approval: September 10, 2019
Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of hypoglycemia. Gvoke VialDx (glucagon injection) is used as a diagnostic aid.
Iluvien (fluocinolone acetonide) Intravitreal Implant
New Indication Approved: March 12, 2025
Date of Original Approval: September 26, 2014
Iluvien (fluocinolone acetonide) is a corticosteroid implant for the treatment of diabetic macular edema and posterior uveitis.
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