The FDA approved insulin icodec-abae for children 10+ with T2D, based on adult ONWARDS data and a single-dose pediatric pharmacokinetic study.

Tezepelumab produced histologic remission in up to 68.9% of patients aged 12+ with EoE vs 3.5% with placebo at week 24, sustained to week 52.

In phase 3 SHINE-2, 50% of mirikizumab induction responders aged 6 to 17 with moderate to severe UC were in clinical remission at week 52.

Keisha L. Gibson, MD, MPH, discusses the FDA approval of Gazyva for childhood-onset INS and its implications for relapse prevention and pediatric care.

Topical botanical Cinainu earned FDA Breakthrough Therapy status for AA in patients aged 2+, supported by phase 2/3 RAAINBOW data in children.

The FDA accepted the Anaphylm NDA resubmission as a class 2 response, setting a March 16, 2027, PDUFA date for the sublingual epinephrine film.

Diana F. Clarke, PharmD, explains how IMPAACT 2023 supported dolutegravir from birth, plus dosing tips and open questions for preterm infants.

New ecopipam analyses show tic reduction within 8 weeks and sustained to 18 months in Tourette syndrome as the FDA weighs approval.