Q4 2025 Recap: Dermatology News and Updates

The fourth quarter of 2025 saw several notable developments in the field of dermatology, with new research on a variety of medications and a few key US Food and Drug Administration (FDA) approvals taking place.

October - December 2025 saw new data on treatments for such conditions as psoriasis, alopecia areata, atopic dermatitis, and hidradenitis suppurativa (HS). In this summary, the HCPLive editorial team reviews some of the biggest dermatology news headlines from Q4, highlighting some of the most significant developments regarding different disease states and providing a peak into Q1 of 2026:

Q4 FDA Decisions

FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

The supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% for children aged 2-5 years with psoriasis was accepted by the FDA in November, leading to a potential expansion in this treatment's indication. Roflumilast cream was formulated as a once-per-day, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor for psoriasis. In this November announcement by Arcutis Biotherapeutics, Inc. a PDUFA target action date of June 29, 2026, was announced for roflumilast cream’s potential FDA approval for patients in this new age range.

Imsidolimab’s Biologics License Application for Treatment of GPP Submitted to FDA

In December, Vanda Pharmaceuticals’s announced the filing of a Biologics License Application (BLA) with FDA officials. The company was seeking an approval of imsidolimab for patients living with generalized pustular psoriasis (GPP) treatment. They described GPP as an area of notable unmet medical need. GPP, the Vanda announcement noted, has a reported prevalence rate varying significantly across geographic areas across the world. In the phase 3 GEMINI studies, imsidolimab's efficacy, with 53% attaining clear skin versus 13% on placebo, was demonstrated.

FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years

In another notable headline from Q4, the FDA approved Arcutis Biotherapeutics’ supplemental new drug application (sNDA) for topical roflumilast (Zoryve) cream 0.05% in mild to moderate atopic dermatitis, specifically among children 2-5 years of age. The FDA based their approval off of findings drawn from the phase 3 INTEGUMENT-PED analysis, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic analysis. This FDA approval represented the 6th for the roflumilast portfolio in almost 3 years.

FDA Approves Adalimumab-aaty (Yuflyma) Pediatric Indications in Hidradenitis Suppurativa, Uveitis

In October FDA decision, Celltrion announced the approval of expanded indications for adalimumab-aaty (Yuflyma) and the drug's unbranded version to include hidradenitis suppurativa (HS) among adolescents ≥ 12 years of age and uveitis (UV) among those ≥ 2 years of age. In the announcement, Celltrion noted adalimumab-aaty was a high-concentration, low-volume, citrate-free biosimilar, interchangeable with Humira. Phase 3 study findings included in the release supported the interchangeability designation by FDA officials. Similar outcomes had been observed in the medication's pharmacokinetics, safety, effectiveness, and immunogenicity.

Q4 Updates in Psoriasis

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

One notable December headline was an announcement by Takeda highlighting positive topline data resulting from a set of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies. In these findings, zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, was shown to be efficacious among adults with moderate-to-severe plaque psoriasis. The company highlighted its aim to present these findings during future medical congresses and submit a New Drug Application (NDA) in 2026.

Risankizumab Effective as Treatment for Psoriasis in Genital, Scalp Regions

In November 2025, risankizumab was suggested in a new study to be an effective and safe drug for individuals with moderate-to-severe psoriasis in the genital and scalp areas of the body. These phase 4 data resulted from an analysis written by investigators such as Eingun James Song, MD, director of clinical research at Frontier Dermatology. Song and colleagues' UnlIMMited study found, in addition to the higher clearance rates seen with risankizumab therapy versus placebo, there were no new safety signals for the drug, supporting its implementation in sensitive bodily regions.

Oral IL-23 Blocker Icotrokinra Sustains High Clearance in Scalp and Genital Psoriasis

In October, new phase 3 data were released by Johnson & Johnson during the Fall Clinical Conference. In these 52-week results, drawn from the ICONIC-TOTAL analysis. These data were regarding icotrokinra, a first-in-class, oral peptide designed to selectively block the interleukin-23 (IL-23) receptor. The medication was assessed by investigators among adults and adolescent patients ≥12 years with plaque psoriasis affecting high-impact and difficult-to-treat areas of the body such as the scalp, hands, genitals, and feet.

Q4 Updates in Atopic Dermatitis

Nemolizumab Rapidly Relieves Itch in Atopic Dermatitis, Prurigo Nodularis

In a post-hoc analysis released in December, investigators confirmed previous findings on nemolizumab relieves itch and sleep issues by the second day of treatment in patients living with moderate-to-severe atopic dermatitis and prurigo nodularis. This study's new data spotlighted the targeting of the IL-31 pathway for individuals with these 2 skin conditions. The investigative team's post-hoc analysis of the ARCADIA and OLYMPIA trials confirmed significant improvements in itch and sleep outcomes by the second day of treatment with nemolizumab use.

Discussing INTEGUMENT-INFANT and Roflumilast Cream 0.05% in Atopic Dermatitis, With Rocco Serrao, MD

An interview was conducted by HCPLive following the completion of enrollment in the open-label, phase 2 INTEGUMENT-INFANT clinical study, assessing investigational once-daily roflumilast (Zoryve) cream 0.05%. Rocco Serrao, MD, an associate clinical professor of Dermatology at Wright State University, spoke in this video about the INTEGUMENT-INFANT study’s assessment of treatment with roflumilast cream 0.05% in infants with mild to moderate atopic dermatitis. Serrao also addressed a gap in available drugs for this particular age cohort.

OX40/OX40 Ligand Target Offers Broader Acting Therapy for Atopic Dermatitis, With Raj Chovatiya, MD, PhD

Raj Chovatiya, MD, PhD, of Northwestern University's Feinberg School of Medicine, spoke following the 2025 ACAAI Annual Scientific Meeting in Orlando, Florida about his conference presentation, ‘7 for 11: Hot Therapeutic Targets in Allergy and Immunology.’ In this HCPLive interview, Chovatiya highlighted key points from his talk on OX40/OX40L, otherwise known as the interaction between the costimulatory TNF receptor OX40 and its ligand, OX40L, as well as its role in atopic disease.

Other Q4 Dermatology Updates

BRAVE-AA-PEDS: Baricitinib Leads to Hair Regrowth in Adolescents with Alopecia Areata

At the 2025 Fall Clinical Dermatology Conference in October, 52-week data were presented suggesting once-per-day use of oral baricitinib (Olumiant) treatment led to notable regrowth of scalp, eyelash, and eyebrow hair among adolescents living with severe alopecia areata following 1 year. Eli Lilly and Incyte released these findings and resulted from the phase 3 BRAVE-AA-PEDS study (NCT05723198). The drug's safety signals observed in adolescents were shown to be consistent with prior data. There were no new safety signals after 1 year of baricitinib therapy.