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Drug |
Pharmacologic Class |
Indication |
More Information |
| Cardiovascular Disease | |||
| Opsynvi (macitentan and tadalafil) | An endothelin receptor antagonist and a phosphodiesterase 5 inhibitor | Treatment of pulmonary arterial hypertension in adult patients of WHO functional class II-III. | Opsynvi, a Single-Tablet Combo Therapy for PAH, Gets FDA Approval |
| Praluent (alirocumab) | Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor | As an adjunct to diet and other low density lipoprotein cholesterol-lowering therapies in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia to reduce LDL-C. | Praluent Approved for Pediatric Patients With Heterozygous Familial Hypercholesterolemia |
| Tryvio (aprocitentan) | Endothelin receptor antagonist | Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. | FDA Approves Tryvio for Patients With Resistant Hypertension |
| Wegovy (semaglutide) | Glucagon-like peptide-1 receptor agonist | To reduce the risk of major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction or nonfatal stroke in adults with established cardiovascular disease and either overweight or obesity. | Wegovy Approved to Reduce MACE Risk in Obese, Overweight Adults |
| Winrevair (sotatercept-csrk) | Recombinant activin receptor type IIA-Fc fusion protein | Treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. | Winrevair Approved for Pulmonary Arterial Hypertension |
| Dermatological Disorders | |||
| Letybo (letibotulinumtoxinA-wlbg) | Acetylcholine release inhibitor and a neuromuscular blocking agent | Treatment of moderate to severe glabellar lines in adults. | Letybo Approved to Treat Moderate to Severe Glabellar Lines |
| Spevigo (spesolimab-sbzo) | Interleukin-36 receptor antagonist | Treatment of generalized pustular psoriasis in adult and pediatric patients 12 years of age and older and weighing at least 40kg. | Spevigo Gets Expanded Approval for Generalized Pustular Psoriasis |
| Gastrohepatic Disorders | |||
| Livmarli (maralixibat) | Ileal bile acid transporter inhibitor | Treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis. | Livmarli Approved for Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis |
| Rezdiffra (resmetirom) | Thyroid hormone receptor-β selective agonist | Treatment of adults with noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis. | FDA Approves Rezdiffra for Nonalcoholic Steatohepatitis With Liver Fibrosis |
| Hematologic Disorders | |||
| Vafseo (vadadustat) | Hypoxia-inducible factor prolyl hydroxylase inhibitor | Treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 3 months. | Vafseo Approved for Anemia Due to CKD in Patients on Dialysis |
| Infectious Diseases | |||
| Edurant PED (rilpivirine) | Non-nucleoside reverse transcriptase inhibitor | Treatment of HIV-1 in combination with other antiretroviral agents in treatment-naïve children 2 years of age and older, weighing at least 14kg with HIV-1 RNA less than or equal to 100,000 copies/mL. | Edurant PED Approved for Pediatric Patients With HIV-1 |
| Metabolic Disorders | |||
| Lenmeldy (atidarsagene autotemcel) | Autologous hematopoietic stem cell-based gene therapy | Treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy | Lenmeldy Approved for Children With Metachromatic Leukodystrophy |
| Musculoskeletal Disorders | |||
| Duvyzat (givinostat) | Histone deacetylase inhibitor | Treatment of patients 6 years of age and older with Duchenne muscular dystrophy. | Duvyzat, a Nonsteroidal Treatment for Duchenne Muscular Dystrophy, Gets FDA Approval |
| Jubbonti (denosumab-bbdz) | RANK ligand inhibitor | To treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. | FDA Approves Denosumab Biosimilars Jubbonti and Wyost |
| Tyenne (tocilizumab-aazg) | Interleukin-6 receptor antagonist | To treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs; adults with giant cell arteritis; and patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis. | FDA Approves Tocilizumab Biosimilar for IV and Subcutaneous Administration |
| Neurologic Disorders | |||
| Ultomiris (ravulizumab-cwvz) |
Long-acting C5 complement inhibitor
|
Treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive. | FDA Approves Ultomiris for Neuromyelitis Optica Spectrum Disorder |
| Oncology | |||
| Besponsa (inotuzumab ozogamicin) |
CD22-directed antibody and cytotoxic drug conjugate
|
Treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia in pediatric patients 1 year and older. | Besponsa Approved for Pediatric Patients With Acute Lymphoblastic Leukemia |
| Breyanzi (lisocabtagene maraleucel) |
CD19-directed genetically modified autologous T-cell immunotherapy
|
Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. | CAR T-Cell Therapy Breyanzi Approved for Relapsed/Refractory CLL or SLL |
| Brukinsa (zanubrutinib) |
Bruton tyrosine kinase inhibitor
|
Treatment of relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy. | Brukinsa Gets Accelerated Approval for Relapsed, Refractory Follicular Lymphoma |
| Elahere (mirvetuximab soravtansine-gynx) |
Folate receptor alpha-directed antibody and microtubule inhibitor conjugate
|
Treatment of adults with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. | Elahere Gets Full Approval for Platinum-Resistant Ovarian Cancer |
| Iclusig (ponatinib) |
Kinase inhibitor
|
Treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. | Iclusig Plus Chemotherapy Gets Accelerated Approval for Newly Diagnosed Ph+ ALL |
| Opdivo (nivolumab) |
Programmed death receptor-1 blocking antibody
|
In combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma. | Opdivo Plus Chemotherapy Approved for First-Line Tx of Urothelial Carcinoma |
| Rybrevant (amivantamab-vmjw) |
Bispecific EGF and MET receptor-directed antibody
|
Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test. | Rybrevant Combo Approved as First-Line Tx for NSCLC With EGFR Exon 20 Insertion Mutations |
| Tevimbra (tislelizumab) |
Programmed death receptor-1 blocking antibody
|
Treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a programmed death-ligand 1 inhibitor. | Tevimbra Approved for Advanced or Metastatic Esophageal Squamous Cell Carcinoma |
| Wyost (denosumab) | RANK ligand inhibitor | To prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. | FDA Approves Denosumab Biosimilars Jubbonti and Wyost |
| Respiratory Disorders | |||
| Xhance (fluticasone propionate) |
Corticosteroid
|
Treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. | Xhance Approved for Chronic Rhinosinusitis Without Nasal Polyps |
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