August 29th 2025
Results from the phase 3 SAPPHIRE trial show significant improvements in motor function in children and adults with spinal muscular atrophy.
Drug Receives FDA Approval for Treating Narcolepsy in Pediatric Patients
October 28th 2018Officials with the FDA have approved Jazz Pharmaceuticals' Xyrem (sodium oxybate) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric patients aged 7 to 17 years with narcolepsy.
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FDA Approves Dupilumab as Additional Maintenance Therapy in Certain Children with Asthma
October 22nd 2018The FDA has approved dupilumab (Dupixent®, Regeneron and Sanofi) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.
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Epilepsy Treatment Receives FDA Approval for Use in Children
September 29th 2018The FDA has expanded the indication of the antiepileptic drug perampanel (FYCOMPA®, Eisai) CIII for monotherapy and adjunctive use in pediatric patients aged 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures.
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Multiple Sclerosis Therapy for Pediatric Patients Approved by FDA
May 12th 2018Officials with the FDA have approved fingolimod (Gilenya, Novartis) for the treatment of relapsing multiple sclerosis in pediatric patients aged 10 years and older, making it the first FDA-approved drug to treat MS in this population.
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