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
Bkemv (eculizumab-aeeb) Injection
Company: Amgen Inc.
Date of Approval: May 28, 2024
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome
Bkemv (eculizumab-aeeb) is a complement inhibitor interchangeable biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Onyda XR (clonidine hydrochloride) Extended-Release Suspension
Company: Tris Pharma, Inc.
Date of Approval: May 24, 2024
Treatment for: ADHD
Onyda XR is a once-daily extended-release oral suspension of clonidine hydrochloride for the treatment of attention-deficit/hyperactivity disorder (ADHD) as monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients over the age of six years.
Yesafili (aflibercept-jbvf) Injection
Company: Biocon Biologics Inc.
Date of Approval: May 20, 2024
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy
Yesafili (aflibercept-jbvf) is a vascular endothelial growth factor (VEGF) inhibitor interchangeable biosimilar to Eylea indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Opuviz (aflibercept-yszy) Injection
Company: Samsung Bioepis Co., Ltd.
Date of Approval: May 20, 2024
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy
Opuviz (aflibercept-yszy) is a vascular endothelial growth factor (VEGF) inhibitor interchangeable biosimilar to Eylea indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Imdelltra (tarlatamab-dlle) for Injection
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.
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 used to treat children aged 2 to 5 years with seizure clusters.
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.
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