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New FDA Drug Approvals for 2024 - Drugs.com Skip to main content

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

Pavblu (aflibercept-ayyh) Injection

Company: Amgen Inc.
Date of Approval: August 23, 2024
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy

Pavblu (aflibercept-ayyh) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Lazcluze (lazertinib) Tablets

Company: Johnson & Johnson Innovative Medicine
Date of Approval: August 20, 2024
Treatment for: Non Small Cell Lung Cancer

Lazcluze (lazertinib) is a kinase inhibitor used in combination with amivantamab for the treatment of certain patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.

Niktimvo (axatilimab-csfr) Injection

Company: Incyte and Syndax Pharmaceuticals
Date of Approval: August 14, 2024
Treatment for: Graft-versus-host disease

Niktimvo (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody used for the treatment of chronic graft-versus-host disease.

Livdelzi (seladelpar) Capsules

Company: Gilead Sciences, Inc.
Date of Approval: August 14, 2024
Treatment for: Primary Biliary Cholangitis

Livdelzi (seladelpar) is a selective peroxisome proliferator-activated receptor delta (PPARδでるた) agonist used for the treatment of primary biliary cholangitis.

Nemluvio (nemolizumab) for Injection

Company: Galderma Laboratories, L.P.
Date of Approval: August 12, 2024
Treatment for: Prurigo Nodularis

Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis.

Neffy (epinephrine) Nasal Spray

Company: ARS Pharmaceuticals, Inc.
Date of Approval: August 9, 2024
Treatment for: Anaphylaxis

neffy® (epinephrine) is an intranasal epinephrine formulation for the emergency treatment of allergic reactions (Type 1), including anaphylaxis, for adults and children ≥30 kg.

Enzeevu (aflibercept-abzv) Injection

Company: Sandoz Inc.
Date of Approval: August 9, 2024
Treatment for: Macular Degeneration

Enzeevu (aflibercept-abzv) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).

Yorvipath (palopegteriparatide) Injection - formerly TransCon PTH

Company: Ascendis Pharma, Inc.
Date of Approval: August 9, 2024
Treatment for: Hypoparathyroidism

Yorvipath (palopegteriparatide) is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults.

Zurnai (nalmefene hydrochloride) Injection

Company: Purdue Pharma L.P.
Date of Approval: August 7, 2024
Treatment for: Opioid Overdose

Zurnai (nalmefene hydrochloride) is an opioid antagonist autoinjector used for the emergency treatment of known or suspected opioid overdose.

Lymphir (denileukin diftitox-cxdl) for Injection

Company: Citius Pharmaceuticals, Inc.
Date of Approval: August 7, 2024
Treatment for: Cutaneous T-cell Lymphoma

Lymphir (denileukin diftitox-cxdl) is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.

Crexont (carbidopa and levodopa) Extended-Release Capsules - formerly IPX203

Company: Amneal Pharmaceuticals LLC
Date of Approval: August 7, 2024
Treatment for: Parkinson's Disease

Crexont (carbidopa/levodopa) is a novel formulation of immediate and extended-release carbidopa/levodopa (CD/LD) for the treatment of Parkinson’s disease.

Voranigo (vorasidenib) Tablets

Company: Servier Pharmaceuticals
Date of Approval: August 6, 2024
Treatment for: Malignant Glioma

Voranigo (vorasidenib) is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for the treatment of Grade 2 IDH-mutant glioma.

Tecelra (afamitresgene autoleucel) Suspension for Intravenous Infusion

Company: Adaptimmune Therapeutics plc
Date of Approval: August 1, 2024
Treatment for: Synovial Sarcoma

Tecelra (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy used for the treatment of adults with unresectable or metastatic synovial sarcoma.

Erzofri (paliperidone palmitate) Extended-Release Injectable Suspension

Company: Luye Pharma Group
Date of Approval: July 26, 2024
Treatment for: Schizophrenia, Schizoaffective Disorder

Erzofri (paliperidone palmitate) is an atypical antipsychotic used for the treatment of schizophrenia and schizoaffective disorder.

Zunveyl (benzgalantamine) Delayed-Release Tablets - formerly ALPHA-1062

Company: Alpha Cognition Inc.
Date of Approval: July 26, 2024
Treatment for: Alzheimer's Disease

Zunveyl (benzgalantamine) is an acetylcholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults.

Leqselvi (deuruxolitinib phosphate) Tablets

Company: Sun Pharmaceutical Industries Inc.
Date of Approval: July 25, 2024
Treatment for: Alopecia Areata

Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata.

Femlyv (ethinyl estradiol and norethindrone acetate) Orally Disintegrating Tablets

Company: Millicent Puerto Rico LLC
Date of Approval: July 22, 2024
Treatment for: Birth Control

Femlyv (ethinyl estradiol and norethindrone acetate) is an orally disintegrating tablet (ODT) formulation of an approved estrogen and progestin combination indicated for use by females of reproductive potential to prevent pregnancy.

Epysqli (eculizumab-aagh) Injection

Company: Samsung Bioepis Co., Ltd.
Date of Approval: July 19, 2024

Epysqli (eculizumab-aagh) is a complement inhibitor biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

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.

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