Datroway (datopotamab deruxtecan-dlnk) Lyophilized Powder for Injection

Date of Approval: January 17, 2025
Company: AstraZeneca and Daiichi Sankyo
Treatment for: Breast Cancer

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.

FDA Approves Datroway (datopotamab deruxtecan-dlnk) for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
Datroway (datopotamab deruxtecan-dlnk) FDA Approval History

Grafapex (treosulfan) Lyophilized Powder for Injection

Date of Approval: January 21, 2025
Company: Medexus Pharmaceuticals Inc.
Treatment for: Stem Cell Transplant Conditioning

Grafapex (treosulfan) is an alkylating agent indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Journavx (suzetrigine) Tablets - formerly VX-548

Date of Approval: January 30, 2025
Treatment for: Pain

Journavx (suzetrigine) is a sodium channel blocker indicated for the treatment of moderate to severe acute pain in adults.

Avtozma (tocilizumab-anoh) Injection

Date of Approval: January 24, 2025
Company: Celltrion, Inc.
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, COVID-19

Avtozma (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra used for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Symbravo (meloxicam and rizatriptan) Tablets - formerly AXS-07

Date of Approval: January 30, 2025
Company: Axsome Therapeutics, Inc.
Treatment for: Migraine

Symbravo (meloxicam and rizatriptan) is a non-steroidal anti-inflammatory drug and triptan combination indicated for the acute treatment of migraine with or without aura in adults.

Onapgo (apomorphine hydrochloride) Subcutaneous Infusion Device - formerly SPN-830

Date of Approval: February 3, 2025
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease

Onapgo (apomorphine hydrochloride) is a continuous subcutaneous infusion formulation of the approved dopaminergic agonist apomorphine for the treatment of motor fluctuations (OFF episodes) in adults with advanced Parkinson’s disease.

Emblaveo (avibactam and aztreonam) Lyophilized Powder for Injection

Date of Approval: February 7, 2025
Company: AbbVie
Treatment for: Intraabdominal Infection

Emblaveo (aztreonam and avibactam) is a monobactam antibacterial and beta-lactamase inhibitor combination used for the treatment of complicated intra-abdominal infections.

Gomekli (mirdametinib) Capsules and Tablets for Oral Suspension

Date of Approval: February 11, 2025
Company: SpringWorks Therapeutics, Inc.
Treatment for: Neurofibromatosis

Gomekli (mirdametinib) is a MEK inhibitor for the treatment of patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Romvimza (vimseltinib) Capsules

Date of Approval: February 14, 2025
Company: Deciphera Pharmaceuticals, Inc.
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.

Vimkunya (chikungunya vaccine, recombinant) Injection

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

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

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

Date of Approval: February 14, 2025
Company: GSK plc
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.

Ospomyv (denosumab-dssb) Injection

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

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

Xbryk (denosumab-dssb) Injection

Date of Approval: February 13, 2025
Company: Samsung Bioepis Co., Ltd.
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Xbryk (denosumab-dssb) 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.

Merilog (insulin aspart-szjj) Injection

Date of Approval: February 14, 2025
Company: sanofi-aventis U.S. LLC
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.

Ctexli (chenodiol) Tablets

Date of Approval: February 21, 2025
Company: Mirum Pharmaceuticals Inc.
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.

Miudella (copper) Intrauterine System

Date of Approval: February 24, 2025
Company: Sebela Women’s Health Inc.
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.

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

Date of Approval: February 28, 2025
Company: Celltrion
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

Date of Approval: February 28, 2025
Company: Celltrion
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.

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

Date of Approval: March 5, 2025
Company: Neurotech Pharmaceuticals, Inc.
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.

Omlyclo (omalizumab-igec) Injection

Date of Approval: March 7, 2025
Company: Celltrion USA
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.

Arbli (losartan potassium) Oral Suspension

Date of Approval: March 13, 2025
Company: Scienture Holdings, Inc.
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.

Gozellix (gallium Ga 68 gozetotide) Injection Kit

Date of Approval: March 20, 2025
Company: Telix Pharmaceuticals Limited
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.

Blujepa (gepotidacin) Tablets

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

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

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

Date of Approval: March 26, 2025
Company: Soleno Therapeutics, Inc.
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.

Conexxence (denosumab-bnht) Injection

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

Date of Approval: March 25, 2025
Company: Fresenius Kabi USA, LLC
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.

Qfitlia (fitusiran) Injection

Date of Approval: March 28, 2025
Company: Sanofi
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.

Vanrafia (atrasentan) Tablets

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

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

Jobevne (bevacizumab-nwgd) Injection

Date of Approval: April 9, 2025
Company: Biocon Biologics Ltd.
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.

Mezofy (aripiprazole) Oral Film

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

HemiClor (chlorthalidone) Tablets

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

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

(penpulimab-kcqx) Injection

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

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

Zevaskyn (prademagene zamikeracel) Gene-Modified Cellular Sheets

Date of Approval: April 28, 2025
Company: Abeona Therapeutics Inc.
Treatment for: Epidermolysis Bullosa

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

Atzumi (dihydroergotamine mesylate) Nasal Powder - formerly STS101

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

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

Imaavy (nipocalimab-aahu) Injection

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

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

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

Date of Approval: May 8, 2025
Company: Verastem Oncology
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.

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

Date of Approval: May 14, 2025
Company: AbbVie Inc.
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.

Nuvaxovid (COVID-19 Vaccine, Adjuvanted) Injectable Suspension - formerly Novavax COVID-19 Vaccine

Date of Approval: May 16, 2025
Company: Novavax, Inc.
Treatment for: COVID-19

Nuvaxovid (COVID-19 Vaccine, Adjuvanted) is a protein-based, non-MRNA vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Brekiya (dihydroergotamine mesylate) Injection

Date of Approval: May 14, 2025
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Migraine, Cluster Headaches

Brekiya (dihydroergotamine mesylate) is a ready-to-use autoinjector presentation of the ergotamine derivative dihydroergotamine mesylate for the acute treatment of migraine and the acute treatment of cluster headaches.

Yutrepia (treprostinil) Inhalation Powder - formerly LIQ861

Date of Approval: May 23, 2025
Company: Liquidia Technologies, Inc.
Treatment for: Pulmonary Arterial Hypertension; Pulmonary Hypertension Associated with Interstitial Lung Disease

Yutrepia (treprostinil) is an inhaled dry powder formulation of the prostacyclin mimetic treprostinil approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Starjemza (ustekinumab-hmny) Injection

Date of Approval: May 22, 2025
Company: Bio-Thera Solutions, Ltd.

Starjemza (ustekinumab-hmny) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Tryptyr (acoltremon) Ophthalmic Solution

Date of Approval: May 28, 2025
Company: Alcon Inc.
Treatment for: Dry Eye Disease

Tryptyr (acoltremon) is a first-in-class TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.

New Drug Approvals Archive for 2025