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FDA Approves Dupilumab for Children Aged 6 to 11 With Moderate to Severe Asthma
Sold under the name Dupixent, dupilumab is a biologic that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.
The FDA Wednesday approved dupilumab as an add-on maintenance treatment for pediatric patients aged 6 to 11 years with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
Sold under the name Dupixent, dupilumab is a biologic that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.
The drug is already approved in patients aged 6 years and older with uncontrolled moderate to severe atopic dermatitis; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
FDA Approves Tislelizumab-jsgr as First-Line Therapy for HER2– Gastric Cancers
January 2nd 2025Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic HER2-negative (HER–) gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1.
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5 Key Drug Approvals and CRLs in 2024
December 27th 2024In 2024, multiple drugs received complete response letters (CRLs), sometimes unrelated to the safety and efficacy of the drug, but patients with schizophrenia gained the first new treatment with a new mechanism of action in decades.
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First Subcutaneous Prophylaxis for Hemophilia A and B With Inhibitors Approved by FDA
December 23rd 2024The approval of concizumab-mtci (Alhemo) injection marks a significant milestone in managing hemophilia A and B with inhibitors by preventing or reducing bleeding episodes in adults and children 12 years and older.
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