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 (PPAR
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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More news resources
- FDA Medwatch Drug Alerts
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