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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

Kisunla (donanemab-azbt) Injection

Company: Eli Lilly and Company
Date of Approval: July 2, 2024
Treatment for: Alzheimer's Disease

Kisunla (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of early symptomatic Alzheimer’s disease.

Pyzchiva (ustekinumab-ttwe) Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: June 28, 2024
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Pyzchiva (ustekinumab-ttwe) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Ahzantive (aflibercept-mrbb) Injection

Company: Formycon AG
Date of Approval: June 28, 2024
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy

Ahzantive (aflibercept-mrbb) is a vascular endothelial growth factor (VEGF) inhibitor 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.

Ohtuvayre (ensifentrine) Inhalation Suspension

Company: Verona Pharma plc
Date of Approval: June 26, 2024
Treatment for: COPD, Maintenance

Ohtuvayre (ensifentrine) is a selective dual inhibitor of the enzymes phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

Tepylute (thiotepa) Injection

Company: Shorla Oncology
Date of Approval: June 25, 2024
Treatment for: Breast Cancer, Ovarian Cancer

Tepylute (thiotepa) is a ready-to-dilute formulation of the approved alkylating agent thiotepa indicated for the treatment of adenocarcinoma of the breast or ovary.

PiaSky (crovalimab-akkz) Injection

Company: Genentech, Inc.
Date of Approval: June 20, 2024
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

PiaSky (crovalimab-akkz) is a complement C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria.

Sofdra (sofpironium) Topical Gel

Company: Botanix Pharmaceuticals Ltd.
Date of Approval: June 18, 2024
Treatment for: Hyperhidrosis

Sofdra (sofpironium) is a topical anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

Capvaxive (pneumococcal 21-valent conjugate vaccine) Injection - formerly V116

Company: Merck
Date of Approval: June 17, 2024
Treatment for: Pneumococcal Disease Prophylaxis

Capvaxive (pneumococcal 21-valent conjugate vaccine) is a 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older.

Vigafyde (vigabatrin) Oral Solution

Company: Pyros Pharmaceuticals, Inc.
Date of Approval: June 17, 2024
Treatment for: Infantile Spasms

Vigafyde (vigabatrin) is a ready-to-use oral solution formulation of the approved anti-seizure medicine vigabatrin used for the treatment of infantile spasms.

Yimmugo (immune globulin intravenous, human-dira) Liquid for Intravenous Injection

Company: Grifols USA, LLC
Date of Approval: June 13, 2024
Treatment for: Primary Immunodeficiency Syndrome

Yimmugo (immune globulin intravenous, human-dira) is an immune globulin liquid for intravenous injection indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older.

Iqirvo (elafibranor) Tablets

Company: Ipsen Biopharmaceuticals, Inc.
Date of Approval: June 10, 2024
Treatment for: Primary Biliary Cholangitis

Iqirvo (elafibranor) is a dual peroxisome-activated receptor (PPAR) alpha/delta (α,δ) agonist used for the treatment of patients with primary biliary cholangitis.

Rytelo (imetelstat) for Injection

Company: Geron Corporation
Date of Approval: June 6, 2024
Treatment for: Myelodysplastic Syndrome

Rytelo (imetelstat) is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

mRESVIA (respiratory syncytial virus vaccine, mRNA) Injection

Company: Moderna, Inc.
Date of Approval: May 31, 2024
Treatment for: RSV

mRESVIA is a modified RNA vaccine that may protect adults aged 60 years and older from lower respiratory tract disease caused by an RSV infection.

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 (clonidine hydrochloride) is a once-daily, extended-release, oral suspension that may be used to treat attention-deficit/hyperactivity disorder (ADHD) in children aged six years and older.

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.

FDA drug approvals archive

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