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.

Children with FASD given choline before age 6 had 9.1% higher nonverbal IQ and 11.3% better working memory vs placebo 5 years after treatment.

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

A joinpoint analysis of 1991 to 2021 YRBSS data found suicidal ideation among US high school students declined through 2009, then increased through 2021.

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

Oral icotrokinra sustained scalp, genital, and hand/foot psoriasis clearance through week 112 in ICONIC-TOTAL, with no new safety signals.