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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 Companion Diagnostic for Tepotinib in MET Exon 14 mNSCLC
November 18th 2024The FDA approved the FoundationOne Liquid CDx to identify patients with metastatic non–small cell lung cancer (mNSCLC) with MET exon 14 skipping alterations who may be eligible for tepotinib (Tepmetko; EMD Serono).
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FDA Approves Danziten for Chronic Myeloid Leukemia Without Mealtime Restrictions
November 14th 2024The FDA has granted approval to Azurity Pharmaceuticals' nilotinib tablets (Danziten), a novel version of the tyrosine kinase inhibitor for chronic myeloid leukemia that can be taken without mealtime restrictions.
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