Skip to main content

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

Emrelis (telisotuzumab vedotin-tllv) Lyophilized Powder for Injection - formerly Teliso-V

Company: AbbVie Inc.
Date of Approval: May 14, 2025
Treatment for: Non Small Cell Lung Cancer

Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous non-small cell lung cancer with high c-Met protein overexpression.

Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) Capsules/Tablets

Company: Verastem Oncology
Date of Approval: May 8, 2025
Treatment for: Ovarian Cancer

Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated recurrent low-grade serous ovarian cancer.

Atzumi (dihydroergotamine mesylate) Nasal Powder - formerly STS101

Company: Satsuma Pharmaceuticals, Inc.
Date of Approval: April 30, 2025
Treatment for: Migraine

Atzumi (dihydroergotamine mesylate) is a nasal powder formulation of the ergotamine derivative dihydroergotamine mesylate for the acute treatment of migraine.

Zevaskyn (prademagene zamikeracel) Gene-Modified Cellular Sheets

Company: Abeona Therapeutics Inc.
Date of Approval: April 29, 2025
Treatment for: Epidermolysis Bullosa

Zevaskyn (prademagene zamikeracel) is an autologous, cell sheet-based gene therapy for the treatment of recessive dystrophic epidermolysis bullosa.

Imaavy (nipocalimab-aahu) Injection

Company: Johnson & Johnson Innovative Medicine
Date of Approval: April 29, 2025
Treatment for: Myasthenia Gravis

Imaavy (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) blocker used for the treatment of generalized myasthenia gravis.

penpulimab-kcqx Injection

Company: Akeso, Inc.
Date of Approval: April 23, 2025
Treatment for: Nasopharyngeal Carcinoma

Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody for use in the treatment of nasopharyngeal carcinoma.

Mezofy (aripiprazole) Oral Film

Company: CMG Pharmaceutical Co., Ltd.
Date of Approval: April 15, 2025
Treatment for: Schizophrenia

Mezofy (aripiprazole) is an oral film formulation of the approved atypical antipsychotic aripiprazole indicated for the treatment of schizophrenia in adult and pediatric patients ages 13 years and older.

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.

HemiClor (chlorthalidone) Tablets

Company: PRM Pharma, LLC
Date of Approval: March 17, 2025
Treatment for: High Blood Pressure

HemiClor (chlorthalidone) is a thiazide-like diuretic indicated for the treatment of hypertension in adults, to lower blood pressure.

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.

FDA drug approvals archive

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer