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Drug |
Pharmacologic Class |
Indication |
More Information |
| Dermatological Disorders | |||
| Filsuvez (birch triterpenes) | Botanical drug product (birch bark extract) | Topical gel for the treatment of partial thickness wounds in patients 6 months of age and older with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. | Filsuvez Topical Gel Approved for Junctional and Dystrophic Epidermolysis Bullosa |
| Zoryve (roflumilast) | Phosphodiesterase type 4 inhibitor | Treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. | Zoryve Topical Foam Approved for Seborrheic Dermatitis |
| Hematological Disorders | |||
| Alvaiz (eltrombopag) | Thrombopoietin receptor agonist | Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding; thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. It should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy; severe aplastic anemia in adults who have had an insufficient response to immunosuppressive therapy. | Alvaiz Approved for ITP, Thrombocytopenia With Hep C, and Severe Aplastic Anemia |
| Casgevy (exagamglogene autoemcel) | CRISPR/Cas9 gene-edited therapy | Cell-based gene therapy for the treatment of sickle cell disease in patients 12 years of age and older. | FDA Approves Gene Therapies Casgevy, Lyfgenia for Sickle Cell Disease |
| Fabhalta (iptacopan) | Factor B inhibitor | Treatment of adults with paroxysmal nocturnal hemoglobinuria. | Fabhalta Approved for Paroxysmal Nocturnal Hemoglobinuria |
| Lyfgenia (lovotibeglogene autoemcel) | Hematopoietic stem cell-based gene therapy | Cell-based gene therapy for the treatment of sickle cell disease in patients 12 years of age and older. | FDA Approves Gene Therapies Casgevy, Lyfgenia for Sickle Cell Disease |
| Wilate (von Willebrand factor/factor VIII complex [human]) | Replacement therapy | Approval expanded to include routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years of age and older with von Willebrand disease. | Wilate Approved for Routine Prophylaxis in Von Willebrand Disease |
| Immune Disorders | |||
| Alyglo (immune globulin intravenous, human-stwk) | Neutralizing immunoglobulin G antibodies | Treatment of primary humoral immunodeficiency in adult patients 17 years of age and older. | Alyglo Approved for Patients With Primary Humoral Immunodeficiency |
| Kidney Disease | |||
| Tarpeyo (budesonide) | Glucocorticoid | To reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy who are at risk for disease progression. | Tarpeyo Approved to Reduce Loss of Kidney Function in IgA Nephropathy |
| Metabolic Disorders | |||
| Wainua (eplontersen) | Transthyretin-directed antisense oligonucleotide | Treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. | Wainua Approved for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis |
| Oncology | |||
| Iwilfin (eflornithine) |
Ornithine decarboxylase inhibitor
|
To reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. | Iwilfin, an Oral Maintenance Therapy for High-Risk Neuroblastoma, Gets FDA Approval |
| Jaypirca (pirtobrutinib) |
Bruton tyrosine kinase inhibitor
|
Treatment of adult patients with 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 BCL-2 inhibitor. | Jaypirca Gains CLL/SLL Indication Through Accelerated Approval Pathway |
| Keytruda (pembrolizumab) |
Programmed death receptor-1 blocking antibody
|
In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer. | Keytruda Plus Padcev Approved for Locally Advanced or Metastatic Urothelial Cancer |
| Welireg (belzutifan) |
Hypoxia-inducible factor inhibitor
|
Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor. | Welireg Approved for Advanced Renal Cell Carcinoma |
| Ophthalmic Disorders | |||
| iDose TR (travoprost intracameral implant) |
Prostaglandin analog
|
To induce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. | FDA Approves Travoprost Intracameral Implant for Glaucoma, Ocular Hypertension |
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