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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

Enflonsia (clesrovimab-cfor) Injection

Company: Merck
Date of Approval: June 9, 2025
Treatment for: RSV Vaccination and Immunization

Enflonsia (clesrovimab-cfor) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for passive immunization for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.

Widaplik (amlodipine, indapamide and telmisartan) Tablets - formerly GMRx2

Company: George Medicines
Date of Approval: June 5, 2025
Treatment for: High Blood Pressure

Widaplik (amlodipine, indapamide and telmisartan) is a single pill, triple combination therapy for the treatment of hypertension, including initiation of treatment.

mNEXSPIKE (COVID-19 Vaccine, mRNA) Injection

Company: Moderna, Inc.
Date of Approval: May 30, 2025
Treatment for: COVID-19

mNEXSPIKE (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Tryptyr (acoltremon) Ophthalmic Solution

Company: Alcon Laboratories, Inc.
Date of Approval: May 28, 2025
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.

Khindivi (hydrocortisone) Oral Solution - formerly ET-400

Company: Eton Pharmaceuticals, Inc.
Date of Approval: May 28, 2025
Treatment for: Adrenocortical Insufficiency

Khindivi (hydrocortisone) is an oral solution formulation of the approved corticosteroid hydrocortisone indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.

Yutrepia (treprostinil) Inhalation Powder - formerly LIQ861

Company: Liquidia Technologies, Inc.
Date of Approval: May 23, 2025
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

Company: Bio-Thera Solutions, Ltd.
Date of Approval: May 22, 2025
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Starjemza (ustekinumab-hmny) 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.

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

Company: Novavax, Inc.
Date of Approval: May 16, 2025
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).

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.

Brekiya (dihydroergotamine mesylate) Injection

Company: Amneal Pharmaceuticals LLC
Date of Approval: May 14, 2025
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.

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.

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.

Zevaskyn (prademagene zamikeracel) Gene-Modified Cellular Sheets

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

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

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.

FDA drug approvals archive

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