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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

Lumisight (pegulicianine)

Company: Lumicell, Inc.
Date of Approval: April 17, 2024
Treatment for: Diagnosis and Investigation

Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.

Selarsdi (ustekinumab-aekn) Injection

Company: Alvotech and Teva Pharmaceuticals
Date of Approval: April 16, 2024
Treatment for: Plaque Psoriasis, Psoriatic Arthritis

Selarsdi (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis and psoriatic arthritis.

Zevtera (ceftobiprole medocaril) for Injection

Company: Basilea Pharmaceutica Ltd.
Date of Approval: April 3, 2024
Treatment for: Bacteremia, Skin and Structure Infection, Pneumonia

Zevtera (ceftobiprole medocaril) is a cephalosporin antibiotic for the treatment of bacteremia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

Voydeya (danicopan) Tablets

Company: AstraZeneca
Date of Approval: March 29, 2024
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Voydeya (danicopan) is a complement factor D inhibitor used for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria.

Risvan (risperidone) for Extended-Release Injectable Suspension

Company: Laboratorios Farmacéuticos Rovi, S.A.
Date of Approval: March 29, 2024
Treatment for: Schizophrenia

Risvan (risperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

Vafseo (vadadustat) Tablets

Company: Akebia Therapeutics, Inc.
Date of Approval: March 27, 2024
Treatment for: Anemia Due to Chronic Kidney Disease

Vafseo (vadadustat) is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Winrevair (sotatercept) for Injection

Company: Merck
Date of Approval: March 26, 2024
Treatment for: Pulmonary Arterial Hypertension

Winrevair (sotatercept) is an activin signaling inhibitor used for the treatment of adults with pulmonary arterial hypertension.

Opsynvi (macitentan and tadalafil) Tablets

Company: Actelion Pharmaceuticals US, Inc.
Date of Approval: March 22, 2024
Treatment for: Pulmonary Arterial Hypertension

Opsynvi (macitentan and tadalafil) is an endothelin receptor antagonist (ERA) and phosphodiesterase 5 (PDE5) inhibitor combination for the treatment of pulmonary arterial hypertension.

Duvyzat (givinostat) Oral Suspension

Company: Italfarmaco Group
Date of Approval: March 21, 2024
Treatment for: Duchenne Muscular Dystrophy

Duvyzat (givinostat) is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older.

Tryvio (aprocitentan) Tablets

Company: Idorsia Ltd.
Date of Approval: March 19, 2024
Treatment for: High Blood Pressure

Tryvio (aprocitentan) is an endothelin receptor antagonist (ERA) for the combination treatment of hypertension that is not adequately controlled with other drugs.

Lenmeldy (atidarsagene autotemcel) Suspension for Intravenous Infusion - formerly OTL-200

Company: Orchard Therapeutics
Date of Approval: March 18, 2024
Treatment for: Metachromatic Leukodystrophy

Lenmeldy (atidarsagene autotemcel) is an autologous hematopoietic stem cell (HSC) gene therapy for the treatment of children with metachromatic leukodystrophy (MLD).

Rezdiffra (resmetirom) Tablets

Company: Madrigal Pharmaceuticals, Inc.
Date of Approval: March 14, 2024
Treatment for: Nonalcoholic Steatohepatitis

Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Tevimbra (tislelizumab-jsgr) Injection

Company: BeiGene, Ltd.
Date of Approval: March 13, 2024
Treatment for: Esophageal Carcinoma

Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor .

Wyost (denosumab-bbdz) Injection

Company: Sandoz Inc.
Date of Approval: March 5, 2024
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Wyost (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Xgeva (denosumab) indicated for 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.

Jubbonti (denosumab-bbdz) Injection

Company: Sandoz
Date of Approval: March 5, 2024
Treatment for: Osteoporosis

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

Tyenne (tocilizumab-aazg) Injection

Company: Fresenius Kabi USA, LLC
Date of Approval: March 5, 2024
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis

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

Letybo (letibotulinumtoxinA-wlbg) Powder for Injection

Company: Hugel, Inc.
Date of Approval: February 29, 2024
Treatment for: Glabellar Lines

Letybo (letibotulinumtoxinA-wlbg) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Simlandi (adalimumab-ryvk) Injection

Company: Alvotech and Teva Pharmaceutical Industries Ltd.
Date of Approval: February 23, 2024
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Simlandi (adalimumab-ryvk) is a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Exblifep (cefepime and enmetazobactam) Injection

Company: Allecra Therapeutics
Date of Approval: February 22, 2024
Treatment for: Urinary Tract Infection

Exblifep (cefepime and enmetazobactam) is a fourth generation cephalosporin and beta lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

Amtagvi (lifileucel) Suspension for Intravenous Infusion

Company: Iovance Biotherapeutics, Inc.
Date of Approval: February 16, 2024
Treatment for: Melanoma

Amtagvi (lifileucel) is a tumor-derived autologous T cell immunotherapy used for the treatment of adult patients with unresectable or metastatic melanoma.

FDA drug approvals archive

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