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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

Tonmya (cyclobenzaprine hydrochloride) - formerly TNX-102 SL

Company: Tonix Pharmaceuticals Holding Corp.
Date of Approval: August 15, 2025
Treatment for: Fibromyalgia

Tonmya (cyclobenzaprine hydrochloride) is a sublingual formulation of cyclobenzaprine hydrochloride indicated for the treatment of fibromyalgia in adults.

Papzimeos (zopapogene imadenovec-drba) Injection

Company: Precigen, Inc.
Date of Approval: August 14, 2025
Treatment for: Recurrent Respiratory Papillomatosis

Papzimeos (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis.

Brinsupri (brensocatib) Tablets

Company: Insmed Incorporated
Date of Approval: August 12, 2025
Treatment for: Bronchiectasis

Brinsupri (brensocatib) is a dipeptidyl peptidase 1 inhibitor for the treatment of patients with bronchiectasis.

Hernexeos (zongertinib) Tablets

Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Date of Approval: August 8, 2025
Treatment for: Non Small Cell Lung Cancer

Hernexeos (zongertinib) is a kinase inhibitor used for the treatment of non-squamous non-small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain activating mutations.

KETARx (ketamine hydrochloride) Injection

Company: PharmaTher Holdings Ltd.
Date of Approval: August 7, 2025
Treatment for: Pain

KETARx (ketamine hydrochloride) is a general anesthetic for use in surgical pain management.

Modeyso (dordaviprone) Capsules

Company: Jazz Pharmaceuticals plc
Date of Approval: August 6, 2025
Treatment for: Malignant Glioma

Modeyso (dordaviprone) is a protease activator used for the treatment of diffuse midline glioma.

Vizz (aceclidine) Ophthalmic Solution - formerly LNZ100

Company: LENZ Therapeutics, Inc.
Date of Approval: July 31, 2025
Treatment for: Presbyopia

Vizz (aceclidine) is a cholinergic agonist indicated for the treatment of presbyopia in adults.

Sephience (sepiapterin) Oral Powder

Company: PTC Therapeutics, Inc.
Date of Approval: July 28, 2025
Treatment for: Phenylketonuria

Sephience (sepiapterin) is a phenylalanine hydroxylase activator used for the treatment of patients with phenylketonuria.

Anzupgo (delgocitinib) Topical Cream

Company: LEO Pharma Inc.
Date of Approval: July 23, 2025
Treatment for: Chronic Hand Eczema

Anzupgo (delgocitinib) is a topical pan-Janus kinase (JAK) inhibitor for the treatment of chronic hand eczema.

Vostally (ramipril) Oral Solution

Company: Rosemont Pharmaceuticals Inc.
Date of Approval: July 23, 2025
Treatment for: High Blood Pressure, Cardiovascular Risk Reduction

Vostally (ramipril) is an oral solution formulation of the approved angiotensin converting enzyme (ACE) inhibitor ramipril used for the treatment of hypertension and to reduce the risk of cardiovascular events.

Kirsty (insulin aspart-xjhz) Injection

Company: Biocon Biologics Inc.
Date of Approval: July 15, 2025
Treatment for: Diabetes Mellitus

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

Ekterly (sebetralstat) Tablets

Company: KalVista Pharmaceuticals, Inc.
Date of Approval: July 3, 2025
Treatment for: Hereditary Angioedema

Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older.

Lynozyfic (linvoseltamab-gcpt) Injection

Company: Regeneron Pharmaceuticals, Inc.
Date of Approval: July 2, 2025
Treatment for: Multiple Myeloma

Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed or refractory multiple myeloma.

Zegfrovy (sunvozertinib) Tablets

Company: Dizal
Date of Approval: July 2, 2025
Treatment for: Non Small Cell Lung Cancer

Zegfrovy (sunvozertinib) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of locally advanced or metastatic non-small cell lung cancer patients with EGFR exon 20 insertion (exon20ins) mutations.

Harliku (nitisinone) Tablets

Company: Cycle Pharmaceuticals
Date of Approval: June 19, 2025
Treatment for: Alkaptonuria

Harliku (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid in adult patients with alkaptonuria.

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.

Arynta (lisdexamfetamine dimesylate) Oral Solution

Company: Azurity Pharmaceuticals, Inc.
Date of Approval: June 16, 2025
Treatment for: ADHD, Binge Eating Disorder

Arynta (lisdexamfetamine dimesylate) is an oral solution formulation of the approved central nervous system (CNS) stimulant lisdexamfetamine for use in the treatment of ADHD and binge eating disorder.

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.

FDA drug approvals archive

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