Anxiety disorders cause much misery and disability in children and adolescents. Psychotherapy and recent advances in drug treatment offer the best hope of improving patients & lives.
Phase 3 trial of omaveloxolone to treat Friedreich ataxia in children aged 2 to <16 begins
Currently, omaveloxolone (Skyclarys) is approved to treat adults and adolescents aged 16 years and older impacted by FA.
Food Insecurity and the Dangers of Infant Formula Dilution
FDA accepts NDA for epinephrine sublingual film to treat type 1 allergic reactions
The federal agency has assigned a target action date of January 31, 2026, for a decision.
Demystifying Infant Formula
FDA will not meet original PDUFA date for sebetralstat to treat HAE
Though the decision will not meet the June 17, 2025, target date, the federal agency anticipates a decision within approximately 4 weeks.
FDA approves new presentation of ustekinumab-stba biosimilar for plaque psoriasis, psoriatic arthritis
The approval for ustekinumab-stba now offers all dosage forms to the reference product, ustekinumab, and is indicated for patients aged 6 to 17 years.