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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

Inluriyo (imlunestrant) Tablets

Company: Eli Lilly and Company
Date of Approval: September 25, 2025

Inluriyo (imlunestrant) is an estrogen receptor antagonist indicated for the treatment of adults with ER-positive, HER2-negative, ESR1- mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Forzinity (elamipretide hydrochloride) Injection

Company: Stealth BioTherapeutics Inc.
Date of Approval: September 19, 2025
Treatment for: Barth Syndrome

Forzinity (elamipretide hydrochloride) is a mitochondrial cardiolipin binder for the treatment of Barth syndrome.

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Injection

Company: Merck
Date of Approval: September 19, 2025

Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) is a programmed death receptor-1 (PD-1)-blocking antibody and endoglycosidase combination indicated for the treatment of multiple types of cancer.

Subvenite (lamotrigine) Oral Suspension

Company: OWP Pharmaceuticals, Inc.
Date of Approval: September 16, 2025
Treatment for: Epilepsy, Bipolar Disorder

Subvenite (lamotrigine) is an oral suspension formulation of the approved anticonvulsant lamotrigine for use in the treatment of epilepsy and bipolar disorder.

Enbumyst (bumetanide) Nasal Spray

Company: Corstasis Therapeutics Inc.
Date of Approval: September 15, 2025

Enbumyst (bumetanide) nasal spray is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including nephrotic syndrome in adults.

Inlexzo (gemcitabine) intravesical system - formerly TAR-200

Company: Johnson & Johnson
Date of Approval: September 9, 2025
Treatment for: Bladder Cancer

Inlexzo (gemcitabine intravesical system) is a treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer

Wayrilz (rilzabrutinib) Tablets

Company: Sanofi
Date of Approval: August 29, 2025
Treatment for: Immune Thrombocytopenia

Wayrilz (rilzabrutinib) is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Bildyos (denosumab-nxxp) Injection

Company: Shanghai Henlius Biotech, Inc. and Organon
Date of Approval: August 29, 2025
Treatment for: Osteoporosis

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

Bilprevda (denosumab-nxxp) Injection

Company: Shanghai Henlius Biotech, Inc. and Organon
Date of Approval: August 29, 2025
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Bilprevda (denosumab-nxxp) 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.

Dawnzera (donidalorsen) Injection

Company: Ionis Pharmaceuticals, Inc.
Date of Approval: August 21, 2025
Treatment for: Hereditary Angioedema

Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older.

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.

FDA drug approvals archive

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