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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

Beqvez (fidanacogene elaparvovec-dzkt) Injection

Company: Pfizer Inc.
Date of Approval: April 26, 2024
Treatment for: Hemophilia B

Beqvez (fidanacogene elaparvovec-dzkt) is an adeno-associated virus vector-based gene therapy for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency).

Xolremdi (mavorixafor) Capsules

Company: X4 Pharmaceuticals
Date of Approval: April 26, 2024
Treatment for: WHIM Syndrome

Xolremdi (mavorixafor) is a CXC chemokine receptor 4 (CXCR4) antagonist indicated in patients 12 years of age and older with WHIM syndrome to increase the number of circulating mature neutrophils and lymphocytes.

Libervant (diazepam) Buccal Film

Company: Aquestive Therapeutics, Inc.
Date of Approval: April 26, 2024
Treatment for: Seizure Clusters

Libervant (diazepam) is a buccal film formulation of the benzodiazepine diazepam that may be given to treat children aged 2 to 5 years with seizure clusters (also known as “acute repetitive seizures”) that are different from their usual seizure pattern.

Hercessi (trastuzumab-strf) for Injection

Company: Accord BioPharma, Inc.
Date of Approval: April 25, 2024

Hercessi (trastuzumab-strf) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

Pivya (pivmecillinam) Tablets

Company: Utility Therapeutics Ltd.
Date of Approval: April 24, 2024
Treatment for: Urinary Tract Infection

Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.

Ojemda (tovorafenib) Tablets and Oral Suspension

Company: Day One Biopharmaceuticals, Inc.
Date of Approval: April 23, 2024
Treatment for: Low-Grade Glioma

Ojemda (tovorafenib) is a type II pan-RAF kinase inhibitor for the treatment of pediatric low-grade glioma.

Anktiva (nogapendekin alfa inbakicept-pmln) - formerly N-803

Company: ImmunityBio, Inc.
Date of Approval: April 22, 2024
Treatment for: Bladder Cancer

Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 superagonist for use in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma.

Lumisight (pegulicianine) for Injection

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.

Xromi (hydroxyurea) Oral Solution

Company: Nova Laboratories, Ltd.
Date of Approval: April 4, 2024
Treatment for: Sickle Cell Anemia

Xromi (hydroxyurea) is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.

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).

FDA drug approvals archive

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