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.
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, and polyarticular juvenile idiopathic arthritis.
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), and chronic spontaneous urticaria.
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 indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, biliary tract cancer, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, triple-negative breast cancer, and malignant pleural mesothelioma.
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.
Furoscix (furosemide) Injection
New Indication Approved: March 6, 2025
Date of Original Approval: October 7, 2022
Furoscix (furosemide) is a loop diuretic indicated for the at-home treatment of edema in adult patients with chronic heart failure or chronic kidney disease.
Neffy (epinephrine) Nasal Spray
Patient Population Altered: March 5, 2025
Date of Original Approval: August 9, 2024
neffy® (epinephrine) is an intranasal epinephrine formulation for the emergency treatment of allergic reactions.
Tevimbra (tislelizumab-jsgr) Injection
New Indication Approved: March 4, 2025
Date of Original Approval: March 13, 2024
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody for use in the treatment of esophageal cancer and gastric cancer.
TNKase (tenecteplase) Lyophilized Powder for Injection
New Indication Approved: February 28, 2025
Date of Original Approval: June 2, 2000
TNKase (tenecteplase) is a tissue plasminogen activator for use in the treatment of ischemic stroke and heart attack.
Soliris (eculizumab) Injection
Patient Population Altered: February 28, 2025
Date of Original Approval: March 16, 2007
Soliris (eculizumab) is a complement inhibitor used in the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, myasthenia gravis, and neuromyelitis optica spectrum disorder.
Odactra (house dust mite allergen extract) Sublingual Tablets
Patient Population Altered: February 27, 2025
Date of Original Approval: March 1, 2017
Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM) allergies.
Sublocade (buprenorphine) Sustained-Release Injection
Labeling Revision Approved: February 21, 2025
Date of Original Approval: November 30, 2017
Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).
Izervay (avacincaptad pegol) Intravitreal Solution
New Indication Approved: February 12, 2025
Date of Original Approval: August 4, 2023
Izervay (avacincaptad pegol) is a complement C5 protein inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Evrysdi (risdiplam) Powder for Oral Solution and Oral Tablets
New Dosage Form Approved: February 11, 2025
Date of Original Approval: August 7, 2020
Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
Adcetris (brentuximab vedotin) Injection
New Indication Approved: February 11, 2025
Date of Original Approval: August 19, 2011
Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, mycosis fungoides, and large B-cell lymphoma.
Susvimo (ranibizumab) Injection for Intravitreal Use via Ocular Implant
New Indication Approved: February 3, 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 and diabetic macular edema.
Ozempic (semaglutide) Injection
New Indication Approved: January 28, 2025
Date of Original Approval: December 5, 2017
Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog for the treatment type 2 diabetes, to reduce the risk of major cardiovascular events in patients with type 2 diabetes and cardiovascular disease, and to reduce the risk of worsening kidney disease and cardiovascular death in patients with type 2 diabetes and chronic kidney disease.
Leqembi (lecanemab-irmb) Injection
New Dosage Regimen: January 27, 2025
Date of Original Approval: January 6, 2023
Leqembi (lecanemab) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.
Enhertu (fam-trastuzumab deruxtecan-nxki) Injection
New Indication Approved: January 27, 2025
Date of Original Approval: December 20, 2019
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer, HER2-low or HER2-ultralow breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors.
Spravato (esketamine) Nasal Spray
New Indication Approved: January 17, 2025
Date of Original Approval: March 5, 2019
Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
Lumakras (sotorasib) Tablets
New Indication Approved: January 16, 2025
Date of Original Approval: May 28, 2021
Lumakras (sotorasib) is a KRAS G12C inhibitor used for the treatment of KRAS G12C-mutated non-small cell lung cancer and KRAS G12C-mutated colorectal cancer.
Calquence (acalabrutinib) Capsules and Tablets
New Indication Approved: January 16, 2025
Date of Original Approval: October 31, 2017
Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, and chronic lymphocytic leukemia or small lymphocytic lymphoma.
Omvoh (mirikizumab-mrkz) Injection
New Indication Approved: January 15, 2025
Date of Original Approval: October 26, 2023
Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist used for the treatment of ulcerative colitis and Crohn’s disease.
Niktimvo (axatilimab-csfr) Injection
New Dosage Form Approved: January 15, 2025
Date of Original Approval: August 14, 2024
Niktimvo (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody used for the treatment of chronic graft-versus-host disease.
Tevimbra (tislelizumab-jsgr) Injection
New Indication Approved: December 26, 2024
Date of Original Approval: March 13, 2024
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody for use in the treatment of esophageal cancer and gastric cancer.
Zepbound (tirzepatide) Injection
New Indication Approved: December 20, 2024
Date of Original Approval: November 8, 2023
Zepbound (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for weight reduction in adults with obesity or adults with overweight, and severe obstructive sleep apnea in adults with obesity.
Braftovi (encorafenib) Capsules
New Indication Approved: December 20, 2024
Date of Original Approval: June 27, 2018
Braftovi (encorafenib) is a kinase inhibitor used for the treatment of melanoma, colorectal cancer, and non-small cell lung cancer with BRAF mutations.
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules
Labeling Revision Approved: December 20, 2024
Date of Original Approval: October 21, 2019
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.
Imcivree (setmelanotide) Injection
Patient Population Altered: December 20, 2024
Date of Original Approval: November 25, 2020
Imcivree (setmelanotide) is a melanocortin-4 receptor agonist used for weight management in patients with rare, genetic diseases of obesity.
Gemtesa (vibegron) Tablets
New Indication Approved: December 18, 2024
Date of Original Approval: December 23, 2020
Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist for use in the treatment of overactive bladder.
Nemluvio (nemolizumab) for Injection
New Indication Approved: December 13, 2024
Date of Original Approval: August 12, 2024
Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of prurigo nodularis and atopic dermatitis.
Vtama (tapinarof) Cream
New Indication Approved: December 12, 2024
Date of Original Approval: May 23, 2022
Vtama (tapinarof) is a topical aryl hydrocarbon receptor (AhR) modulating agent used for the treatment of plaque psoriasis and atopic dermatitis.
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