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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.

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