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 biosimilar/interchangeable 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, Gastric Cancer
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody for use in the treatment of esophageal cancer and gastric cancer.
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, Crohn's Disease, Ulcerative Colitis
Selarsdi (ustekinumab-aekn) 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.
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.
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 used to treat children aged 2 to 5 years with seizure clusters.
Myhibbin (mycophenolate mofetil) Oral Suspension
Date of Approval: May 1, 2024
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Organ Transplant, Rejection Prophylaxis
Myhibbin (mycophenolate mofetil) is an antimetabolite immunosuppressant used for the prophylaxis of organ rejection.
Imdelltra (tarlatamab-dlle) for Injection
Date of Approval: May 16, 2024
Company: Amgen
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.
Opuviz (aflibercept-yszy) Injection
Date of Approval: May 20, 2024
Company: Samsung Bioepis Co., Ltd.
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.
Yesafili (aflibercept-jbvf) Injection
Date of Approval: May 20, 2024
Company: Biocon Biologics Inc.
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.
Bkemv (eculizumab-aeeb) Injection
Date of Approval: May 28, 2024
Company: Amgen Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis
Bkemv (eculizumab-aeeb) is a complement inhibitor interchangeable biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myasthenia gravis.
Onyda XR (clonidine hydrochloride) Extended-Release Suspension
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.
mRESVIA (respiratory syncytial virus vaccine, mRNA) Injection
Date of Approval: May 31, 2024
Company: Moderna, Inc.
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.
Rytelo (imetelstat) for Injection
Date of Approval: June 6, 2024
Company: Geron Corporation
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).
Iqirvo (elafibranor) Tablets
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.
Yimmugo (immune globulin intravenous, human-dira) Liquid for Intravenous Injection
Date of Approval: June 13, 2024
Company: Grifols
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.
Capvaxive (pneumococcal 21-valent conjugate vaccine) Injection - formerly V116
Date of Approval: June 17, 2024
Company: Merck
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
Date of Approval: June 17, 2024
Company: Pyros Pharmaceuticals, Inc.
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.
Sofdra (sofpironium) Topical Gel
Date of Approval: June 18, 2024
Company: Botanix Pharmaceuticals Ltd.
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
PiaSky (crovalimab-akkz) Injection
Date of Approval: June 20, 2024
Company: Genentech, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria
PiaSky (crovalimab-akkz) is a complement C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria.
Ohtuvayre (ensifentrine) Inhalation Suspension
Date of Approval: June 26, 2024
Company: Verona Pharma plc
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
Date of Approval: June 25, 2024
Company: Shorla Oncology
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.
Pyzchiva (ustekinumab-ttwe) Injection
Date of Approval: June 28, 2024
Company: Samsung Bioepis Co., Ltd.
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.
Nypozi (filgrastim-txid) Injection
Date of Approval: June 28, 2024
Company: Tanvex BioPharma USA, Inc.
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.
Ahzantive (aflibercept-mrbb) Injection
Date of Approval: June 28, 2024
Company: Formycon AG
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.
Kisunla (donanemab-azbt) Injection
Date of Approval: July 2, 2024
Company: Eli Lilly and Company
Treatment for: Alzheimer's Disease
Kisunla (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of early symptomatic Alzheimer’s disease.
Epysqli (eculizumab-aagh) Injection
Date of Approval: July 19, 2024
Company: Samsung Bioepis Co., Ltd.
Epysqli (eculizumab-aagh) is a complement inhibitor biosimilar to Soliris for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
Femlyv (ethinyl estradiol and norethindrone acetate) Orally Disintegrating Tablets
Date of Approval: July 22, 2024
Company: Millicent Puerto Rico LLC
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.
Leqselvi (deuruxolitinib phosphate) Tablets
Date of Approval: July 25, 2024
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Alopecia Areata
Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata.
Erzofri (paliperidone palmitate) Extended-Release Injectable Suspension
Date of Approval: July 26, 2024
Company: Luye Pharma Group
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
Date of Approval: July 26, 2024
Company: Alpha Cognition Inc.
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.
Tecelra (afamitresgene autoleucel) Suspension for Intravenous Infusion
Date of Approval: August 1, 2024
Company: Adaptimmune Therapeutics plc
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.
Voranigo (vorasidenib) Tablets
Date of Approval: August 6, 2024
Company: Servier Pharmaceuticals LLC
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.
Crexont (carbidopa and levodopa) Extended-Release Capsules - formerly IPX203
Date of Approval: August 7, 2024
Company: Amneal Pharmaceuticals, Inc.
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.
Zurnai (nalmefene hydrochloride) Injection
Date of Approval: August 7, 2024
Company: Purdue Pharma L.P.
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
Date of Approval: August 7, 2024
Company: Citius Pharmaceuticals, Inc.
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.
Neffy (epinephrine) Nasal Spray
Date of Approval: August 9, 2024
Company: ARS Pharmaceuticals, Inc.
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
Date of Approval: August 9, 2024
Company: Sandoz
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
Date of Approval: August 9, 2024
Company: Ascendis Pharma, Inc.
Treatment for: Hypoparathyroidism
Yorvipath (palopegteriparatide) is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults.
Nemluvio (nemolizumab) for Injection
Date of Approval: August 12, 2024
Company: Galderma
Treatment for: Prurigo Nodularis, Atopic Dermatitis
Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of prurigo nodularis and atopic dermatitis.
Livdelzi (seladelpar) Capsules
Date of Approval: August 14, 2024
Company: Gilead Sciences, Inc.
Treatment for: Primary Biliary Cholangitis
Livdelzi (seladelpar) is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist used for the treatment of primary biliary cholangitis.
Niktimvo (axatilimab-csfr) Injection
Date of Approval: August 14, 2024
Company: Incyte and Syndax Pharmaceuticals
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.
Lazcluze (lazertinib) Tablets
Date of Approval: August 20, 2024
Company: Johnson & Johnson
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.
Pavblu (aflibercept-ayyh) Injection
Date of Approval: August 23, 2024
Company: Amgen, Inc.
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.
Boruzu (bortezomib) Injection
Date of Approval: September 5, 2024
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma, Mantle Cell Lymphoma
Boruzu (bortezomib) is a ready-to-use injectable proteasome inhibitor for the treatment of multiple myeloma and mantle cell lymphoma.
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Injection
Date of Approval: September 12, 2024
Company: Genentech, Inc.
Treatment for: Non Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Alveolar Soft Part Sarcoma
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) is a programmed death-ligand 1 (PD-L1) blocking antibody and endoglycosidase combination used for the treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.
Ebglyss (lebrikizumab-lbkz) injection
Date of Approval: September 13, 2024
Treatment for: Atopic Dermatitis
Ebglyss (lebrikizumab-lbkz) is a targeted IL-13 inhibitor used for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and children 12 years and older who weigh at least 88 pounds (40 kg).
Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) Injection
Date of Approval: September 13, 2024
Company: Genentech
Treatment for: Multiple Sclerosis
Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) is a CD20-directed cytolytic antibody and hyaluronidase combination used for the treatment of people with relapsing and progressive multiple sclerosis (MS).
Miplyffa (arimoclomol) Capsules
Date of Approval: September 20, 2024
Company: Zevra Therapeutics, Inc.
Treatment for: Niemann-Pick Disease
Miplyffa (arimoclomol) is a heat shock protein amplifier used in combination with miglustat for the treatment of Niemann-Pick disease Type C.
Aqneursa (levacetylleucine) Granules for Oral Suspension - formerly IB1001
Date of Approval: September 24, 2024
Company: IntraBio Inc.
Treatment for: Niemann-Pick Disease
Aqneursa (levacetylleucine) is a modified amino acid used for the treatment Niemann-Pick disease type C.
Cobenfy (xanomeline and trospium chloride) Capsules
Date of Approval: September 26, 2024
Company: Bristol Myers Squibb
Treatment for: Schizophrenia
Cobenfy (xanomeline and trospium chloride) is a muscarinic agonist and muscarinic antagonist combination indicated for the treatment of schizophrenia in adults.
Flyrcado (flurpiridaz F 18) Injection
Date of Approval: September 27, 2024
Company: GE HealthCare
Treatment for: Positron Emission Tomography Imaging
Flyrcado (flurpiridaz F 18) is a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent used for the detection of myocardial ischemia and infarction.
Otulfi (ustekinumab-aauz) Injection
Date of Approval: September 27, 2024
Company: Fresenius Kabi
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Otulfi (ustekinumab-aauz) 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.
Itovebi (inavolisib) Tablets
Date of Approval: October 10, 2024
Company: Genentech, Inc.
Treatment for: Breast Cancer
Itovebi (inavolisib) is a phosphatidylinositol 3-kinase (PI3K) alpha inhibitor used for the combination treatment of PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
Hympavzi (marstacimab-hncq) Injection
Date of Approval: October 11, 2024
Company: Pfizer Inc.
Treatment for: Hemophilia A, Hemophilia B
Hympavzi (marstacimab-hncq) is a tissue factor pathway inhibitor (TFPI) antagonist used for the treatment of adults and adolescents with hemophilia A or B without inhibitors.
Imuldosa (ustekinumab-srlf) Injection
Date of Approval: October 10, 2024
Company: Dong-A ST
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Imuldosa (ustekinumab-srlf) 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.
Vyalev (foscarbidopa and foslevodopa) Injection - formerly ABBV-951
Date of Approval: October 16, 2024
Company: AbbVie Inc.
Treatment for: Parkinson's Disease
Vyalev (foscarbidopa and foslevodopa) is a carbidopa prodrug and levodopa prodrug combination indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Vyloy (zolbetuximab-clzb) Injection
Date of Approval: October 18, 2024
Company: Astellas Pharma Inc.
Treatment for: Gastric Cancer
Vyloy (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody used for the combination treatment of patients with HER2-negative gastric cancer or gastroesophageal junction cancer whose tumors are CLDN18.2 positive.
Orlynvah (sulopenem etzadroxil and probenecid) Tablets
Date of Approval: October 25, 2024
Company: Iterum Therapeutics plc
Treatment for: Urinary Tract Infection
Orlynvah (sulopenem etzadroxil and probenecid) is a penem antibacterial and renal tubular transport inhibitor combination used for the treatment of uncomplicated urinary tract infections in adult women.
Emrosi (minocycline hydrochloride) Extended-Release Capsules - formerly DFD-29
Date of Approval: November 1, 2024
Company: Journey Medical Corporation
Treatment for: Rosacea
Emrosi (minocycline hydrochloride) is a low-dose, modified-release capsule formulation of the approved tetracycline-class drug minocycline indicated to treat the inflammatory lesions of rosacea in adults.
Aucatzyl (obecabtagene autoleucel) Suspension for Intravenous Infusion
Date of Approval: November 8, 2024
Company: Autolus Therapeutics plc
Treatment for: Acute Lymphoblastic Leukemia
Aucatzyl (obecabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Kebilidi (eladocagene exuparvovec-tneq) Suspension for Intraputaminal Infusion - formerly Upstaza
Date of Approval: November 13, 2024
Company: PTC Therapeutics, Inc.
Treatment for: AADC Deficiency
Kebilidi (eladocagene exuparvovec-tneq) is a gene replacement therapy for use in the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.
Danziten (nilotinib tartrate) Tablets
Date of Approval: November 7, 2024
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Chronic Myelogenous Leukemia
Danziten (nilotinib tartrate) is a kinase inhibitor used for the treatment of Philadelphia chromosome positive chronic myeloid leukemia.
Revuforj (revumenib) Tablets
Date of Approval: November 15, 2024
Company: Syndax Pharmaceuticals, Inc.
Treatment for: Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Revuforj (revumenib) is a first-in-class menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
Ziihera (zanidatamab-hrii) Lyophilized Powder for Injection
Date of Approval: November 20, 2024
Company: Jazz Pharmaceuticals plc
Treatment for: Biliary Tract Tumor
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody for the treatment of HER2-positive biliary tract cancer.
Attruby (acoramidis) Tablets
Date of Approval: November 22, 2024
Company: BridgeBio Pharma, Inc.
Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis
Attruby (acoramidis) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
Imkeldi (imatinib mesylate) Oral Solution
Date of Approval: November 22, 2024
Company: Shorla Oncology Inc.
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Diseases, Myeloproliferative Disorders, Systemic Mastocytosis, Hypereosinophilic Syndrome, Chronic Eosinophilic Leukemia, Dermatofibrosarcoma Protuberans, Gastrointestinal Stromal Tumor
Imkeldi (imatinib mesylate) is an oral liquid formulation of the approved kinase inhibitor imatinib used for the treatment of certain forms of leukemia and other cancers.
Rapiblyk (landiolol) Lyophilized Powder for Injection
Date of Approval: November 22, 2024
Company: AOP Orphan Pharmaceuticals GmbH
Treatment for: Supraventricular Tachycardia
Rapiblyk (landiolol) is an ultra-short acting cardioselective beta-1 adrenergic blocker for for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.
Yesintek (ustekinumab-kfce) Injection
Date of Approval: November 29, 2024
Company: Biocon Biologics Ltd.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Yesintek (ustekinumab-kfce) 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.
Bizengri (zenocutuzumab-zbco) Injection
Date of Approval: December 4, 2024
Company: Merus N.V.
Treatment for: Non Small Cell Lung Cancer, Pancreatic Cancer
Bizengri (zenocutuzumab-zbco) is a bispecific HER2- and HER3-directed antibody for the treatment of patients with neuregulin 1 fusion positive (NRG1+) non-small cell lung cancer (NSCLC) and NRG1+ pancreatic adenocarcinoma.
Unloxcyt (cosibelimab-ipdl) Injection
Date of Approval: December 13, 2024
Company: Checkpoint Therapeutics, Inc.
Treatment for: Squamous Cell Carcinoma
Unloxcyt (cosibelimab-ipdl) is a programmed death ligand-1 (PD-L1) blocking antibody used for the treatment of cutaneous squamous cell carcinoma.
Crenessity (crinecerfont) Capsules and Oral Solution
Date of Approval: December 13, 2024
Company: Neurocrine Biosciences, Inc.
Treatment for: Congenital Adrenal Hyperplasia
Crenessity (crinecerfont) is a corticotropin-releasing factor type 1 receptor antagonist indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia.
Steqeyma (ustekinumab-stba) Injection
Date of Approval: December 17, 2024
Company: Celltrion, Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis
Steqeyma (ustekinumab-stba) 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.
Ensacove (ensartinib) Capsules
Date of Approval: December 18, 2024
Company: Xcovery Holdings, Inc.
Treatment for: Non Small Cell Lung Cancer
Ensacove (ensartinib) is an anaplastic lymphoma kinase (ALK) inhibitor used for the treatment of ALK-positive non-small cell lung cancer.
Ryoncil (remestemcel-L-rknd) Cell Suspension for Intravenous Infusion
Date of Approval: December 18, 2024
Company: Mesoblast Limited
Treatment for: Graft Versus Host Disease
Ryoncil (remestemcel-L-rknd) is an allogeneic bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.
Symvess (acellular tissue engineered vessel-tyod) for Surgical Vascular Implantation
Date of Approval: December 19, 2024
Company: Humacyte, Inc.
Treatment for: Revascularization Procedures
Symvess (acellular tissue engineered vessel-tyod) is a first-in-class, implantable bioengineered human tissue used to treat vascular trauma in the extremities.
Tryngolza (olezarsen) Injection
Date of Approval: December 19, 2024
Company: Ionis Pharmaceuticals, Inc.
Treatment for: Familial Chylomicronemia Syndrome
Tryngolza (olezarsen) is an apoC-III-directed antisense oligonucleotide indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
Alhemo (concizumab-mtci) Injection
Date of Approval: December 20, 2024
Company: Novo Nordisk
Treatment for: Hemophilia A with Inhibitors, Hemophilia B with Inhibitors
Alhemo (concizumab-mtci) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B with inhibitors.
Alyftrek (deutivacaftor, tezacaftor and vanzacaftor)
Date of Approval: December 20, 2024
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Alyftrek (deutivacaftor, tezacaftor and vanzacaftor) is a next-in-class, triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for use in the treatment of cystic fibrosis.
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection
Date of Approval: December 27, 2024
Company: Bristol Myers Squibb
Treatment for: Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Gastric Cancer
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a programmed death receptor-1 (PD-1)-blocking antibody and hyaluronidase combination for use in the treatment of renal cell carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
New drug approvals archive
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.