Dermatology Times November 2025 Recap

Clearances, Approvals, Updates, and Recommendations

FDA Issues Warnings to Websites Illegally Marketing Botox and Related Products

The FDA issued 18 warning letters to websites illegally selling unapproved and misbranded botulinum toxin products, citing serious safety risks including botulism-related adverse events.

Arcutis Completes Enrollment in Phase 2 Study of Roflumilast Cream for Infant AD

Arcutis advances pediatric atopic dermatitis treatment with roflumilast cream, completing enrollment in key INTEGUMENT-INFANT trial.

UK Clinicians Gain First NICE-Approved CHE JAK Inhibitor

Clinical trials DELTA 1, 2, 3, and DELTA FORCE demonstrated significant improvements in CHE severity and patient-reported outcomes with delgocitinib.

Alys Pharmaceuticals Doses First Patient in Phase 1/1b Trial of ALY-301 for Chronic Urticaria

The first-in-class mast cell–selective c-Kit inhibitor ALY-301 enters clinical testing for cold urticaria in Germany.

Roflumilast sNDA Accepted for Plaque Psoriasis in Patients 2 to 5 Years

A Prescription Drug User Fee Act target action date is set for June 29, 2026.

Veradermics Launches Phase 2/3 Trial for VDPHL01, a Potential First FDA-Approved Oral Treatment for FPHL

Veradermics initiates a groundbreaking trial for VDPHL01, an oral minoxidil treatment, addressing female pattern hair loss with innovative solutions.

Big Studies and Big Data

PH-762 Demonstrates Safety and Local Efficacy in Skin Cancer

Phio Pharmaceuticals reveals promising results for PH-762, a novel siRNA therapy targeting skin cancer, showcasing effective tumor clearance and safety.

Real-World Data Reveal Increased NMSC Risk in Atopic Dermatitis

Findings suggest immune dysregulation and chronic inflammation in atopic dermatitis may contribute to increased skin cancer susceptibility.

Oral C5aR Inhibitor INF904 Shows Early Efficacy in HS and CSU Phase 2a Trials

The topline data support advancing INF904 into larger, controlled trials as a potential convenient alternative to injectable biologics.

Training, Transparency, and Teledermatology: New Survey Uncovers Key Priorities in Patient Care

A recent survey reveals patients prioritize board-certified dermatologists and increasingly favor teledermatology for faster, accessible care.

DecisionDx-Melanoma GEP Test Accurately Predicts SLN Positivity and Refines Recurrence Risk Assessment, New Data Shows

New findings showcase DecisionDx-Melanoma's effectiveness in predicting sentinel lymph node positivity and enhancing recurrence risk assessment in melanoma patients.

Guselkumab Demonstrates Durable Joint-Protective Effects Through 48 Weeks in Active PsA

New long-term findings reveal guselkumab (TREMFYA) as the only IL-23 inhibitor effectively preventing joint damage in active psoriatic arthritis.

Market, Pharma, and Specialty News

Castle Biosciences Launches 487-Gene Test for AD Care

Castle Biosciences’ new test uses molecular signatures from lesional skin to guide systemic therapy decisions in moderate to severe AD.

Incyte's New Ingenuity Awards Program Focuses on Empowering the HS Community

Incyte launches Ingenuity Awards to empower HS community, funding innovative patient-driven initiatives for better treatment and outcomes in hidradenitis suppurativa.

BOTOX Cosmetic Day 2025: Vince Bertucci, MD, FRCPC, Discusses Diversity, Psychological Benefits, and Natural Outcomes

Discover how BOTOX Cosmetic Day highlights natural results and patient satisfaction, backed by new research from ASDS on diverse populations and effective treatment strategies.

Strides for Skin Health Equity

Surgical Collaboration Strengthens HS Outcomes Across Disease Stages

At the 10th Annual Symposium on Hidradenitis Suppurativa Advances, Ralph George, MD, FRCS, emphasized that the growing collaboration between medical and surgical management is redefining the role of procedures in HS.

The Hair Report: Expert Perspectives on Hair Disorders in Skin of Color

Experts discuss hair loss challenges and treatments for skin of color, highlighting the importance of early intervention and accurate diagnosis.

Innovations Transforming How We Manage HS

Discover the latest insights on hidradenitis suppurativa treatment, emerging therapies, and the importance of compassionate care for patients.

The Dermatology Clinician's Role in Detecting Intimate Partner Violence

Stacey Swinehart, DNP, FNP-BC, DCNP, CNL, shares key takeaways for clinicians from the SDNP's recent webinar on detecting intimate partner violence among patients.

Key Considerations and Best Practices for Aesthetic Procedures in Skin of Color

Nada Elbuluk, MD, MSc, and Nkem Ugonabo, MD, MPH, discuss safe aesthetic procedures for skin of color, emphasizing tailored techniques and the importance of understanding unique skin biology.

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