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

neffy (epinephrine)Nasal Spray

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

neffy(R) (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.

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.

Nypozi (filgrastim-txid)Injection

Company: Tanvex BioPharma USA, Inc.
Date of Approval: June 28, 2024
Treatment for: Neutropenia, Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation, Bone Marrow Transplantation, Peripheral Progenitor Cell Transplantation

Nypozi (filgrastim-txid) is a leukocyte growth factor biosimilar to Neupogen indicated for the treatment of neutropenia, neutropenia associated with chemotherapy, neutropenia associated with radiation, bone marrow transplantation, and peripheral progenitor cell transplantation.

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.

FDA drug approvals archive

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of drugclasses.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Stay up-to-date
Recently Approved
  • neffy

    neffy® (epinephrine) is an intranasal epinephrine formulation for the emergency...

  • Enzeevu

    Enzeevu (aflibercept-abzv) is a vascular endothelial growth factor (VEGF)...

  • Yorvipath

    Yorvipath (palopegteriparatide) is a parathyroid hormone analog (PTH(1-34))...

More drug approvals