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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic approvals, Approval process, New indications & dosage forms

Jobevne (bevacizumab-nwgd) Injection

Company: Biocon Biologics Ltd.
Date of Approval: April 9, 2025
Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Jobevne (bevacizumab-nwgd) is a vascular endothelial growth factor inhibitor biosimilar to Avastin used for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vanrafia (atrasentan) Tablets

Company: Novartis Pharmaceuticals Corporation
Date of Approval: April 2, 2025
Treatment for: Immunoglobulin A Nephropathy

Vanrafia (atrasentan) is an endothelin A receptor antagonist used for proteinuria reduction in primary immunoglobulin (IgA) nephropathy.

Qfitlia (fitusiran) Injection

Company: Sanofi
Date of Approval: March 28, 2025
Treatment for: Hemophilia A, Hemophilia A with Inhibitors, Hemophilia B, Hemophilia B with Inhibitors

Qfitlia (fitusiran) is an antithrombin-directed small interfering ribonucleic acid for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors.

Vykat XR (diazoxide choline) Extended-Release Tablets - formerly DCCR

Company: Soleno Therapeutics, Inc.
Date of Approval: March 26, 2025
Treatment for: Prader-Willi Syndrome

Vykat XR (diazoxide choline) is an extended-release formulation of the crystalline salt of diazoxide for use in the treatment of hyperphagia in patients with Prader-Willi syndrome.

Blujepa (gepotidacin) Tablets

Company: GlaxoSmithKline
Date of Approval: March 25, 2025
Treatment for: Urinary Tract Infection

Blujepa (gepotidacin) is a triazaacenaphthylene bacterial type II topoisomerase inhibitor used for the treatment of uncomplicated urinary tract infections.

Conexxence (denosumab-bnht) Injection

Company: Fresenius Kabi USA, LLC
Date of Approval: March 25, 2025
Treatment for: Osteoporosis

Conexxence (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

Bomyntra (denosumab-bnht) Injection

Company: Fresenius Kabi USA, LLC
Date of Approval: March 25, 2025
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Bomyntra (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.

Gozellix (gallium Ga 68 gozetotide) Injection Kit

Company: Telix Pharmaceuticals Limited
Date of Approval: March 20, 2025
Treatment for: Positron Emission Tomography Imaging

Gozellix (gallium Ga 68 gozetotide) is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Arbli (losartan potassium) Oral Suspension

Company: Scienture Holdings, Inc.
Date of Approval: March 13, 2025
Treatment for: High Blood Pressure, Diabetic Kidney Disease

Arbli (losartan potassium) is an oral liquid formulation of the approved angiotensin II receptor blocker losartan for use in the treatment of hypertension and diabetic nephropathy.

Omlyclo (omalizumab-igec) Injection

Company: Celltrion USA
Date of Approval: March 7, 2025
Treatment for: Asthma, Maintenance, Chronic Rhinosinusitis With Nasal Polyps, Food Allergies, Urticaria

Omlyclo (omalizumab-igec) is an anti-IgE antibody interchangeable biosimilar to Xolair for the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and urticaria.

Encelto (revakinagene taroretcel-lwey) Intravitreal Implant - formerly NT-501

Company: Neurotech Pharmaceuticals, Inc.
Date of Approval: March 5, 2025
Treatment for: Macular Telangiectasia Type 2

Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2.

Stoboclo (denosumab-bmwo) Injection - formerly CT-P41

Company: Celltrion USA
Date of Approval: February 28, 2025
Treatment for: Osteoporosis

Stoboclo (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

Osenvelt (denosumab-bmwo) Injection - formerly CT-P41

Company: Celltrion USA
Date of Approval: February 28, 2025
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Osenvelt (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.

Miudella (copper) Intrauterine System

Company: Sebela Pharmaceuticals, Inc.
Date of Approval: February 24, 2025
Treatment for: Birth Control

Miudella is a copper-containing intrauterine device (IUD) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.

Ctexli (chenodiol) Tablets

Company: Mirum Pharmaceuticals Inc.
Date of Approval: February 21, 2025
Treatment for: Cerebrotendinous Xanthomatosis

Ctexli (chenodiol) is a synthetic form of the bile acid chenodeoxycholic acid indicated for the treatment of cerebrotendinous xanthomatosis in adults.

Romvimza (vimseltinib) Capsules

Company: Deciphera Pharmaceuticals, Inc.
Date of Approval: February 14, 2025
Treatment for: Tenosynovial Giant Cell Tumor

Romvimza (vimseltinib) is a switch-control kinase inhibitor of colony stimulating factor 1 receptor (CSF1R) for the treatment of patients with tenosynovial giant cell tumor.

Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) Lyophilized Powder for Injection

Company: GlaxoSmithKline
Date of Approval: February 14, 2025
Treatment for: Meningococcal Disease Prophylaxis

Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.

Vimkunya (chikungunya vaccine, recombinant) Injection

Company: Bavarian Nordic A/S
Date of Approval: February 14, 2025
Treatment for: Chikungunya Disease Prevention

Vimkunya (chikungunya vaccine, recombinant) is a vaccine used for the prevention of disease caused by chikungunya virus.

Merilog (insulin aspart-szjj) Injection

Company: Sanofi
Date of Approval: February 14, 2025
Treatment for: Diabetes Mellitus

Merilog (insulin aspart-szjj) is a rapid acting human insulin analog biosimilar to NovoLog (insulin aspart) indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Ospomyv (denosumab-dssb) Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: February 13, 2025
Treatment for: Osteoporosis

Ospomyv (denosumab-dssb) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

FDA drug approvals archive

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