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Drug |
Pharmacologic Class |
Indication |
More Information |
| Hematological Disorders | |||
| Zynteglo (betibeglogene autotemcel) | Hematopoietic stem cell gene therapy | Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. | Zynteglo Approved as First Gene Therapy for Beta-Thalassemia |
| Metabolic Disorders | |||
| Xenpozyme (Olipudase alfa-rpcp) | Hydrolytic lysosomal sphingomyelin-specific enzyme replacement therapy | Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients. | Xenpozyme Approved for Acid Sphingomyelinase Deficiency |
| Neurologic Disorders | |||
| Zonisade (zonisamide oral suspension) | Carbonic anhydrase inhibitor | Adjunctive therapy for the treatment of partial-onset seizures in patients 16 years of age and older. | Oral Suspension Formulation of Zonisamide Gets FDA Approval |
| Oncology | |||
| Enhertu (fam-trastuzumab deruxten-nxki) | HER2-directed antibody + topoisomerase inhibitor conjugate | Treatment of adults with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 mutations and who have received a prior systemic therapy. | Enhertu Drug Monograph |
| Nubeqa (darolutamide) | Androgen receptor inhibitor | Treatment of adults with metastatic hormone-sensitive prostate cancer. | Nubeqa Drug Monograph |
| Pemazyre (pemigatinib) | Fibroblast growth factor receptor inhibitor | Treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 rearrangement. | Pemazyre Drug Monograph |
| Ophthalmic Disorders | |||
| Cimerli (ranibizumab-eqrn) | Vascular endothelial growth factor inhibitor | Treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. | Cimerli Approved as Interchangeable Biosimilar to Lucentis |
| Psychiatric Disorders | |||
| Auvelity (dextromethorphan HBr-bupropion HCI) | Noncompetitive N-methyl-D-aspartate receptor antagonist and a norepinephrine and dopamine reuptake inhibitor | Treatment of adults with major depressive disorder. | Auvelity Approved for Major Depressive Disorder |
| Urological Disorders | |||
| Kyzatrex (testosterone undecanoate) | Testosterone undecanoate | Testosterone replacement therapy in adult males for conditions associated with deficiency or absence of endogenous testosterone. | FDA Approves Oral Testosterone Replacement Therapy Kyzatrex |
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