Dermatology Times October 2025 Recap

Clearances, Approvals, Updates, and Recommendations

FDA Recommends Against Immediate BLA Filing for Melanoma Vaccine Candidate

The vaccine is designed to stimulate T cell responses against IDO1- and PD-L1–positive cells within the tumor microenvironment.

Sitryx Advances Novel Oral Therapy SYX-5219 for Atopic Dermatitis with FDA IND Clearance

Sitryx Therapeutics advances SYX-5219 for moderate to severe AD, aiming for a first-in-class oral treatment with potential for lasting disease remission.

FDA Expands Roflumilast Access to Children as Young as Age 2

The approval represents the sixth FDA authorization for roflumilast since 2022.

FDA Approves Cemiplimab as Adjuvant Immunotherapy for High-Risk CSCC

Regeneron's cemiplimab-rwlc gains FDA approval as the first immunotherapy for high-risk cutaneous squamous cell carcinoma, significantly improving disease-free survival.

FDA Alerts Clinicians to Serious Complications with Radiofrequency Microneedling Devices

FDA warns of serious risks associated with RF microneedling, urging patient education and careful provider training to ensure safety in aesthetic dermatology.

FDA Accepts RP1 BLA Resubmission for Advanced Melanoma

The resubmission includes additional data and analyses addressing prior FDA concerns and is now classified as a complete response under a Class II review.

ICYMI: Quoin's QRX003 Receives FDA Orphan Drug Status for Netherton Syndrome

Quoin Pharmaceuticals' QRX003 granted FDA Orphan Drug Designation, advancing treatment for Netherton Syndrome, a rare dermatological disease.

FDA Modernizes Biosimilar Approval to Cut Costs and Speed Access

Updated FDA policies eliminate many comparative efficacy trials, reducing biosimilar development time and cost by relying more on analytical testing.

Big Studies and Big Data

MoonLake Shares Findings from Dual Phase 3 Trials of Sonelokimab

While VELA-1 achieved statistical significance under all analyses, VELA-2 narrowly missed its composite primary endpoint due to higher-than-expected placebo outcomes.

Pan-JAK Inhibition Proves Effective Across CHE Subtypes

Delgocitinib showed consistent efficacy in atopic, irritant, allergic, and hyperkeratotic forms of chronic hand eczema in pooled trial data.

STRATA Excimer Laser and JAK Inhibitors Delivers Superior Vitiligo Repigmentation

A new trial reveals that combining Excimer laser with JAK inhibitors significantly enhances vitiligo treatment outcomes, ensuring safety and durability.

Investigating a New 4% Glycyrrhetinic Acid Treatment Approach for SSD

A novel 4% glycyrrhetinic acid scalp gel shows rapid relief for mild to moderate seborrheic dermatitis, enhancing treatment options with herbal ingredients.

Azitra's ATR-01 Shows Promise in Preclinical Studies for Ichthyosis Vulgaris

Azitra reveals promising preclinical results for ATR-01, a novel treatment targeting ichthyosis vulgaris, paving the way for future clinical trials.

Significant Quality of Life Gains Seen After CO₂ Laser Therapy for HS

CO₂ laser treatment significantly enhances quality of life for hidradenitis suppurativa patients, showing promising outcomes in a large prospective study.

Upadacitinib Achieves Positive Phase 3 Results in Non-Segmental Vitiligo

In 2 replicate phase 3 trials, once-daily upadacitinib 15 mg significantly improved total and facial repigmentation in adults and adolescents with non-segmental vitiligo, with a safety profile consistent with prior indications.

Market, Pharma, and Specialty News

WHO Adds Psoriasis Biologics, AD Moisturizers, and Sunscreen for Albinism to Essential Medicines List

WHO includes adalimumab and ustekinumab for psoriasis, plus sunscreen for albinism, enhancing global skin health and access to essential treatments.

LEO Pharma Finalizes Acquisition of Spesolimab for GPP

Spesolimab joins LEO Pharma’s dermatology portfolio to further expand spesolimab’s reach for patients worldwide with generalized pustular psoriasis.

IPC Brings Clarity to Topical Therapy Failure

Discover the latest IPC consensus on psoriasis severity reclassification, enhancing treatment strategies for better patient outcomes and quality of life.

FDA Renews Funding for SELVA Study in Rare Lymphatic Disorder

Palvella surpassed enrollment goals in its Phase 3 SELVA trial, enrolling 51 patients at leading US vascular anomaly centers.

Phase 3 Ritlecitinib Trial Uses Synthetic Controls to Test Higher Dose Efficacy

The trial evaluates ritlecitinib's efficacy for severe alopecia areata, utilizing innovative external placebo controls for enhanced patient outcomes.

Strides for Skin Health Equity

New Hope for Chronic Hives on World Urticaria Day 2025

World Urticaria Day raises awareness about chronic spontaneous and inducible urticaria, highlighting treatment advancements and patient challenges.

Vitiligo Disease Duration Linked to Depression Severity

Findings suggest that physical activity alone may not meet the psychosocial needs of vitiligo patients, emphasizing the need for targeted mental health care.

Unveiling the Psychosocial Impact and Lifestyle Factors Associated with Rosacea in China

New research highlights the psychosocial impact of rosacea on Chinese patients, linking lifestyle factors and comorbidities to quality of life.

Derm Dispatch: Lessons from the Eczema Community

The episode underscores the clinical value of listening to patient advocates who bring firsthand understanding of disease impact.

Biologics Reshape Emergency Dermatology

New evidence supports biologic agents as precise, better-tolerated alternatives to systemic immunosuppressants for life-threatening dermatologic emergencies.

Derm Dispatch: A Lifelong Journey with Eczema and the Power of Compassionate Care

Chava Wald shares her inspiring journey with AD, advocating for patient empowerment and compassionate care during Eczema Awareness Month.

What Living With Psoriasis Taught Me About Adherence—and Why Clinical Research Must Change

Stephanie Alvarez, marketing director of Cognivia, details her experience with psoriasis and why she believes clinical trials should reflect more real-world patients and scenarios.

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