New Drug Approvals Archive for 2024
See also: New Indications and Dosage Forms for 2024
Zelsuvmi (berdazimer sodium) Topical Gel
Date of Approval: January 5, 2024
Company: Ligand Pharmaceuticals Incorporated
Treatment for: Molluscum Contagiosum
Zelsuvmi (berdazimer sodium) is a nitric oxide-releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.
Eohilia (budesonide) Oral Suspension - formerly TAK-721
Date of Approval: February 9, 2024
Company: Takeda Pharmaceutical Company Limited
Treatment for: Eosinophilic Esophagitis
Eohilia (budesonide oral suspension) is a mucoadherent formulation of the approved corticosteroid budesonide used for the treatment of eosinophilic esophagitis.
Aurlumyn (iloprost) Injection
Date of Approval: February 13, 2024
Company: Eicos Sciences Inc.
Treatment for: Frostbite
Aurlumyn (iloprost) is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.
Amtagvi (lifileucel) Suspension for Intravenous Infusion
Date of Approval: February 16, 2024
Company: Iovance Biotherapeutics, Inc.
Treatment for: Melanoma
Amtagvi (lifileucel) is a tumor-derived autologous T cell immunotherapy used for the treatment of adult patients with unresectable or metastatic melanoma.
Simlandi (adalimumab-ryvk) Injection
Date of Approval: February 23, 2024
Company: Alvotech and Teva Pharmaceutical Industries Ltd.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis
Simlandi (adalimumab-ryvk) is a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Exblifep (cefepime and enmetazobactam) Injection
Date of Approval: February 22, 2024
Company: Allecra Therapeutics
Treatment for: Urinary Tract Infection
Exblifep (cefepime and enmetazobactam) is a fourth generation cephalosporin and beta lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).
Letybo (letibotulinumtoxinA-wlbg) Powder for Injection
Date of Approval: February 29, 2024
Company: Hugel, Inc.
Treatment for: Glabellar Lines
Letybo (letibotulinumtoxinA-wlbg) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Jubbonti (denosumab-bbdz) Injection
Date of Approval: March 5, 2024
Company: Sandoz
Treatment for: Osteoporosis
Jubbonti (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
Wyost (denosumab-bbdz) Injection
Date of Approval: March 5, 2024
Company: Sandoz
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy
Wyost (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Xgeva (denosumab) indicated for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.
Tyenne (tocilizumab-aazg) Injection
Date of Approval: March 5, 2024
Company: Fresenius Kabi
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis
Tyenne (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra used for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Tevimbra (tislelizumab-jsgr) Injection
Date of Approval: March 13, 2024
Company: BeiGene, Ltd.
Treatment for: Esophageal Carcinoma
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor .
Rezdiffra (resmetirom) Tablets
Date of Approval: March 14, 2024
Company: Madrigal Pharmaceuticals, Inc.
Treatment for: Nonalcoholic Steatohepatitis
Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
Lenmeldy (atidarsagene autotemcel) Suspension for Intravenous Infusion - formerly OTL-200
Date of Approval: March 18, 2024
Company: Orchard Therapeutics
Treatment for: Metachromatic Leukodystrophy
Lenmeldy (atidarsagene autotemcel) is an autologous hematopoietic stem cell (HSC) gene therapy for the treatment of children with metachromatic leukodystrophy (MLD).
Tryvio (aprocitentan) Tablets
Date of Approval: March 19, 2024
Company: Idorsia Ltd.
Treatment for: High Blood Pressure
Tryvio (aprocitentan) is an endothelin receptor antagonist (ERA) for the combination treatment of hypertension that is not adequately controlled with other drugs.
Opsynvi (macitentan and tadalafil) Tablets
Date of Approval: March 22, 2024
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension
Opsynvi (macitentan and tadalafil) is an endothelin receptor antagonist (ERA) and phosphodiesterase 5 (PDE5) inhibitor combination for the treatment of pulmonary arterial hypertension.
Duvyzat (givinostat) Oral Suspension
Date of Approval: March 21, 2024
Company: Italfarmaco Group
Treatment for: Duchenne Muscular Dystrophy
Duvyzat (givinostat) is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older.
Winrevair (sotatercept) for Injection
Date of Approval: March 26, 2024
Company: Merck
Treatment for: Pulmonary Arterial Hypertension
Winrevair (sotatercept) is an activin signaling inhibitor used for the treatment of adults with pulmonary arterial hypertension.
Vafseo (vadadustat) Tablets
Date of Approval: March 27, 2024
Company: Akebia Therapeutics, Inc.
Treatment for: Anemia Due to Chronic Kidney Disease
Vafseo (vadadustat) is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Voydeya (danicopan) Tablets
Date of Approval: March 29, 2024
Company: AstraZeneca
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
Date of Approval: March 29, 2024
Company: Laboratorios Farmacéuticos Rovi, S.A.
Treatment for: Schizophrenia
Risvan (risperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.
Zevtera (ceftobiprole medocaril) for Injection
Date of Approval: April 3, 2024
Company: Basilea Pharmaceutica Ltd.
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.
Xromi (hydroxyurea) Oral Solution
Date of Approval: April 4, 2024
Company: Nova Laboratories, Ltd.
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.
Selarsdi (ustekinumab-aekn) Injection
Date of Approval: April 16, 2024
Company: Alvotech and Teva Pharmaceuticals
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.
Lumisight (pegulicianine) for Injection
Date of Approval: April 17, 2024
Company: Lumicell, Inc.
Treatment for: Diagnosis and Investigation
Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.
Rezenopy (naloxone hydrochloride) Nasal Spray
Date of Approval: April 19, 2024
Company: Summit Biosciences Inc.
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.
Anktiva (nogapendekin alfa inbakicept-pmln) - formerly N-803
Date of Approval: April 22, 2024
Company: ImmunityBio, Inc.
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.
Ojemda (tovorafenib) Tablets and Oral Suspension
Date of Approval: April 23, 2024
Company: Day One Biopharmaceuticals, Inc.
Treatment for: Low-Grade Glioma
Ojemda (tovorafenib) is a type II pan-RAF kinase inhibitor for the treatment of pediatric low-grade glioma.
Pivya (pivmecillinam) Tablets
Date of Approval: April 24, 2024
Company: Utility Therapeutics Ltd.
Treatment for: Urinary Tract Infection
Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.
Beqvez (fidanacogene elaparvovec-dzkt) Injection
Date of Approval: April 26, 2024
Company: Pfizer Inc.
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 (congenital factor IX deficiency).
Hercessi (trastuzumab-strf) for Injection
Date of Approval: April 25, 2024
Company: Accord BioPharma, Inc.
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.
Xolremdi (mavorixafor) Capsules
Date of Approval: April 26, 2024
Company: X4 Pharmaceuticals
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
Date of Approval: April 26, 2024
Company: Aquestive Therapeutics, Inc.
Treatment for: Seizure Clusters
Libervant (diazepam) is a buccal film formulation of the benzodiazepine diazepam that may be given to treat children aged 2 to 5 years with seizure clusters (also known as “acute repetitive seizures”) that are different from their usual seizure pattern.
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