Drug Pipeline News

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from October 2025.

If approved, this UC indication would add to pediatric indications of ustekinumab for psoriasis and active psoriatic arthritis.

FDA moves to remove unapproved ingestible fluoride drugs for children, citing microbiome and thyroid concerns.

The FDA has assigned a target action date of February 28, 2026, for a potential expanded indication of pegvaliase-pqpz to include adolescents with PKU.

A pair of phase 3 trials showed that AbbVie's daily upadacitinib 15 mg led to a 50% reduction in T-VASI 50 and a 75% reduction in F-VASI 75 at 48 weeks among adolescents 12 years and older.

New one-year data showed that baricitinib continued scalp, eyebrow, and eyelash regrowth in adolescents with severe alopecia areata.

The FDA acknowledged that the primary endpoint was met but that "data do not support the effectiveness of low-dose atropine in children with myopia," according to Sydnexis.

Tezepelumab received FDA approval for CRSwNP in patients 12 years and older, supported by strong phase 3 data.

Indication expansions include hidradenitis suppurativa for patients 12 years and up, as well as for patients with uveitis aged 2 years and older.

FDA accepts MannKind’s sBLA for Afrezza in children and adolescents with diabetes.

The once-daily, steroid-free cream can be used anywhere on the body for treatment and for any duration, according to Arcutis.

Watch our FDA pipeline news recap for the month of September 2025 as well as a preview of a key PDUFA date in October.

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from September 2025.

From another potential treatment for pediatric atopic dermatitis, to STI therapy for uncomplicated urogenital gonorrhea, take a look ahead at key PDUFA dates in Q4.

FDA approves guselkumab as the first IL-23 inhibitor for children 6 years or older with plaque psoriasis or psoriatic arthritis.

The approval expands on the previous indication of children 5 years and older with HoFH, approved in 2023.

The FDA has authorized Essilor Stellest eyeglass lenses to correct myopia and slow progression in children, offering a lower-risk option than contacts.

Observations were not specific to apitegromab, and the CRL did not cite any other approvability concerns related to efficacy and safety data.

The FDA announces significant updates on acetaminophen risks in pregnancy and approves leucovorin calcium for treating CFD in children.

Zilganersen met the primary endpoint of gait stabilization, showing statistically significant benefit on gait speed and favorable safety.

The planned phase 2 study of SAT-3247 will evaluate safety, tolerability, and functional outcomes in children with Duchenne muscular dystrophy.

The federal agency granted accelerated approval to elamipretide HCl to treat patients with Barth syndrome.

Rezpegaldesleukin improved disease severity and patient-reported outcomes in a phase 2b atopic dermatitis trial with sustained benefit.

The Phase 3 SURPASS-PEDS trial found tirzepatide improved glycemic control and weight outcomes in youth-onset type 2 diabetes, with benefits lasting one year.

New phase 3 data show icotrokinra maintained high PASI90 responses in pediatric and adult patients at 1 year.