6 Dermatology Headlines You Missed in December 2025

The dermatology field saw a number of significant news headlines covered by HCPLive in the final month of 2025, with December representing 1 of the most dynamic months of the year in the skin health space.

These December news stories included recent findings on the use of once-daily oral zasocitinib for plaque psoriasis, an interview regarding new data on roflumilast cream 0.05% for atopic dermatitis, and a variety of US Food and Drug Administration (FDA)-related headlines. Cumulatively, these stories provide insight into what has transpired and what is to come in the field of dermatology in 2026:

Research News:

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

In 1 notable December headline, Takeda announced positive topline findings resulting from a set of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled analyses. These data point to the efficacy of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, among adult patients living with moderate-to-severe plaque psoriasis. The company noted its plans to present these data at medical congresses and submit a New Drug Application (NDA) in 2026.

Nemolizumab Rapidly Relieves Itch in Atopic Dermatitis, Prurigo Nodularis

In a post-hoc analysis released in December, prior data suggesting nemolizumab relieves itch and sleep disturbances by the second day of use in those with moderate-to-severe atopic dermatitis and prurigo nodularis was confirmed. These findings spotlighted the targeting of the interleukin (IL)-31 pathway for those with these 2 skin diseases. This post-hoc analysis of ARCADIA and OLYMPIA studies confirmed significant improvements in itch and sleep outcomes by the second day of treatment with this medication.

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

Following the completion of enrollment in the open-label, phase 2 INTEGUMENT-INFANT clinical study, assessing investigational once-daily roflumilast (Zoryve) cream 0.05%, HCPLive conducted an interview with Rocco Serrao, MD, an associate clinical professor of Dermatology at Wright State University, who highlighted the INTEGUMENT-INFANT study’s evaluation of roflumilast cream 0.05% aMONG infants with mild to moderate atopic dermatitis and addressed a gap in available drugs for this age cohort.

FDA News:

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

Another notable headline from December was Vanda Pharmaceuticals’s announcement of its filing of a Biologics License Application (BLA) with the FDA, seeking approval of imsidolimab for generalized pustular psoriasis (GPP) treatment. Vanda described GPP as an area of unmet medical need, with the skin disease’s reported rate of prevalence varying significantly across geographic regions around the world. The phase 3 GEMINI studies were described as having demonstrated imsidolimab's efficacy, with 53% attaining clear skin versus 13% on placebo.

FDA Proposes Expanding Active Ingredient List for Sunscreens

The FDA announced a proposal in December to expand the current list of active sunscreen ingredients to include bemitrizinol. This announcement describes the agency’s aim to modernize and expand sunscreen options as part of a larger Office of Nonprescription Drugs initiative. FDA officials have, as a result of this initiative, issued this new proposal to include bemotrizinol, given its minimal level of skin absorption and low irritation risk. The ingredient, officials noted, may be a safe option for adults and children over 6 months of age.

sNDA for Ameluz-PDT as a Treatment for Superficial Basal Cell Carcinoma Submitted to FDA

An announcement by Biofrontera Inc. was released early in December 2025 regarding the company’s submission of a supplemental New Drug Application (sNDA) to the FDA for Ameluz-PDT (photodynamic therapy) as a superficial basal cell carcinoma (sBCC) treatment. This December 2 release highlights Biofrontera’s sNDA and the complete efficacy results from recent phase 3 research and 1-year follow-up. The company also highlighted its combined safety analysis drawing from both European and US clinical research in the basal cell carcinoma space.