January 2024: Notable Drug Approvals

Drug

Pharmacologic Class

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Dermatological Disorders
Zelsuvmi (berdazimer topical gel) Nitric oxide releasing topical antiviral Treatment of molluscum contagiosum in adults and pediatric patients 1 year of age and older. Zelsuvmi Approved for Topical Treatment of Molluscum Contagiosum
Gastrohepatic Disorders
Dupixent (dupilumab) Interleukin-4 receptor alpha antagonist Treatment of pediatric patients aged 1 to 11 years, weighing at least 15kg, with eosinophilic esophagitis. Dupixent Approved for Pediatric Eosinophilic Esophagitis
Hematological Disorders
Casgevy (exagamglogene autotemcel) CRISPR/Cas9 gene-edited therapy Treatment of patients aged 12 years and older with transfusion-dependent β-thalassemia. Gene Therapy Casgevy Approved for Transfusion-Dependent Beta Thalassemia
Neurologic Disorders
Gammagard Liquid (immune globulin infusion 10%) Immune globulin To improve neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy. Gammagard Liquid Approved for Chronic Inflammatory Demyelinating Polyneuropathy
HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) Immune globulin + recombinant human hyaluronidase Treatment of chronic inflammatory demyelinating polyneuropathy as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. HyQvia Approved for Chronic Inflammatory Demyelinating Polyneuropathy
Oncology
Balversa (erdafitinib)
Kinase inhibitor
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least 1 line of prior systemic therapy. Balversa Gets Full Approval for Advanced or Metastatic Urothelial Carcinoma
Keytruda (pembrolizumab)
Programmed death receptor-1 blocking antibody
In combination with chemoradiotherapy for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. Keytruda Plus Chemoradiotherapy Approved for FIGO 2014 Stage III-IVA Cervical Cancer