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Endocrine Disorders
Tzield (teplizumab-mzwv) Anti-CD3 monoclonal antibody To delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older who have stage 2 type 1 diabetes. Tzield Approved to Delay Onset of Stage 3 Type 1 Diabetes
Hematologic Disorders
Hemgenix (etranacogene dezaparvovec-drlb) An adeno-associated virus vector-based gene therapy Treatment of hemophila B (congenital factor IX deficiency). First Gene Therapy for Hemophilia B Gets FDA Approval
Infectious Disease
Rebyota (fecal microbiota, live-jslm)   Fecal microbiota suspension For the prevention of recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following antibiotic treatment for recurrent CDI. Rebyota Approved to Prevent Recurrence of Clostridioides difficile Infection
Vemlidy (tenofovir alafenamide) HBV nucleoside analog reverse transcriptase inhibitor Treatment of chronic hepatitis B virus infection in pediatric patients 12 years of age and older with compensated liver disease. Vemlidy Approved for Pediatric Patients With Chronic HBV Infection
Neurologic Disorders
Sezaby (phenobarbital sodium powder for injection) Barbiturate For the treatment of neonatal seizures in term and preterm infants. Sezaby Approved to Treat Seizures in Term and Preterm Infants
Oncology
Adcetris (brentuximab vedotin) CD30-directed antibody-drug conjugate Treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.. Adcetris Approved for Pediatric Patients With High Risk Classical Hodgkin Lymphoma
Elahere (mirvetuximab soravtansine-gynx) Folate receptor alpha (FRα)-directed antibody and microtubule inhibitor Treatment of adult patients 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 Granted Accelerated Approval for Platinum-Resistant Ovarian Cancer
Imjudo (tremelimumab-actl) Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody In combination with durvalumab and platinum-based chemotherapy for the treatment of adults with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase genomic tumor aberrations. Imjudo Plus Imfinzi and Chemotherapy Approved for Metastatic NSCLC
Libtayo (cemiplimab-rwlc) Programmed death receptor-1 blocking antibody First-line treatment of adults with non-small cell lung cancer with no EGFR, ALK or ROS1 aberrations. Libtayo Drug Monograph
Tecvayli (teclistamab-cqyv) Bispecific B-cell maturation antigen-directed CD3 T-cell engager Treatment of adult patients with relapsed or refractory multiple myeloma, who previously received 4 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. Tecvayli Approved for Relapsed or Refractory Multiple Myeloma