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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.
TNX-102 SL Now Fourth FDA-Approved Treatment for Fibromyalgia
August 18th 2025This approval brings the total to 4 of medications approved to treat fibromyalgia; in addition to cyclobenzaprine HCl sublingual tablets (TNX-102 SL; Tonmya; Tonix Pharmaceuticals), there are pregabalin (Lyrica; Viatris), duloxetine (Cymbalta; Eli Lilly), and milnacipran (Savella; AbbVie).
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