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
Imdelltra (tarlatamab-dlle)
Company: Amgen Inc.
Date of Approval: May 16, 2024
Treatment for: Small Cell Lung Cancer
Imdelltra (tarlatamab-dlle) is a first-in-class, bispecific delta-like ligand 3 (DLL3)-directed CD3 T cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Myhibbin (mycophenolate mofetil) Oral Suspension
Company: Azurity Pharmaceuticals, Inc.
Date of Approval: May 1, 2024
Treatment for: Organ Transplant, Rejection Prophylaxis
Myhibbin (mycophenolate mofetil) is an antimetabolite immunosuppressant used for the prophylaxis of organ rejection.
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
Treatment for: Breast Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma
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.
Rezenopy (naloxone hydrochloride) Nasal Spray
Company: Summit Biosciences Inc.
Date of Approval: April 19, 2024
Treatment for: Opioid Overdose
Rezenopy (naloxone hydrochloride) nasal spray is an opioid antagonist for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.
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.
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.
FDA drug approvals archive
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More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
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