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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

Yeztugo (lenacapavir) Tablets and Injection

Company: Gilead Sciences, Inc.
Date of Approval: June 18, 2025
Treatment for: Pre-Exposure Prophylaxis of HIV

Yeztugo (lenacapavir) is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1.

Andembry (garadacimab-gxii) Injection

Company: CSL Behring
Date of Approval: June 16, 2025
Treatment for: Hereditary Angioedema

Andembry (garadacimab-gxii) is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients aged 12 years and older.

Zusduri (mitomycin) for Intravesical Solution - formerly UGN-102

Company: UroGen Pharma Ltd.
Date of Approval: June 12, 2025
Treatment for: Bladder Cancer

Zusduri (mitomycin) is a sustained release, hydrogel-based formulation of mitomycin for intravesical treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Ibtrozi (taletrectinib) Capsules

Company: Nuvation Bio Inc.
Date of Approval: June 11, 2025
Treatment for: Non Small Cell Lung Cancer

Ibtrozi (taletrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

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.

Xifyrm (meloxicam) Injection

Company: Azurity Pharmaceuticals, Inc.
Date of Approval: June 5, 2025
Treatment for: Pain

Xifyrm (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) for use in the management of moderate-to-severe pain.

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.

FDA drug approvals archive

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