The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
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The FDA has expanded the approval of Dupixent® (dupilumab; Regeneron and Sanofi) to include patients aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Dupixent, an interleukin-4 receptor alpha antagonist, is currently approved for moderate to severe atopic dermatitis in patients ≥12 years old who are not adequately controlled with topical prescription therapies or when they are not advisable.
Topline results from a phase 3 study investigating dupilumab in the treatment of pediatric patients with severe atopic dermatitis showed that the interleukin-4 receptor alpha antagonist was both safe and effective in this patient population.