Dermatology Times July 2025 Recap

Clearances, Approvals, Updates, and Recommendations

Zelsuvmi, First At-Home Prescription Gel for Molluscum Contagiosum, Launches in US

Zelsuvmi is the first FDA-approved at-home treatment for molluscum contagiosum, now available for patients aged ≥1 via retail and mail-order pharmacies.

Deuruxolitinib Launches in US for Treatment of Severe Alopecia Areata

Sun Pharmaceuticals has launched deuruxolitinib (Leqselvi) in the US, offering a new treatment for adults with severe alopecia areata.

Johnson & Johnson Submits NDA for Icotrokinra in Plaque Psoriasis

Johnson & Johnson submitted an NDA for icotrokinra, a promising new treatment for moderate to severe plaque psoriasis in adults and adolescents.

FDA Accepts sNDA for Sotyktu in PsA

Bristol Myers Squibb's deucravacitinib gains global regulatory acceptance for treating active psoriatic arthritis, promising a new oral treatment option.

Castle Biosciences’ DecisionDx-Melanoma Test Earns FDA Breakthrough Device Designation

Castle Biosciences’ DecisionDx-Melanoma test plays a role in melanoma management with precise risk stratification, enhancing patient outcomes and reducing unnecessary surgeries.

FDA Approves LEO Pharma's Delgocitinib for Adults With Moderate to Severe Chronic Hand Eczema

The approval makes delgocitinib cream the first and only approved therapy in the US for CHE in adults.

Big Studies and Big Data

New Research Highlights Zabalafin Hydrogel's Novel Multitargeted Approach to AD Treatment

A new paper highlights Alphyn Biologics' Zabalafin Hydrogel as a promising multitarget therapy for atopic dermatitis, addressing inflammation, itch, and bacterial complications.

New Data Support Delgocitinib for Sensitive Skin Areas

Delgocitinib ointment shows promise as an effective, well-tolerated treatment for atopic dermatitis on the face and neck, enhancing patient satisfaction and reducing adverse effects.

APG777 Demonstrates High EASI-75 Response Rates in Moderate to Severe Atopic Dermatitis

New 16-week data from the phase 2 APEX clinical trial demonstrated the anti-IL-13 antibody's efficacy across all key endpoints.

Data Show Spesolimab Maintains Skin Clarity Between GPP Flares

Spesolimab effectively targets the IL-36 receptor, reducing inflammation and preventing flares in generalized pustular psoriasis, offering new hope for patients.

Tralokinumab Shows Hand Relief in ADHAND Trial

LEO Pharma reveals promising interim results for tralokinumab in treating moderate to severe atopic dermatitis on hands, enhancing patient quality of life.

Abrocitinib Reduces Itch and Lesions in AD Trial

Abrocitinib significantly improves lesion severity and pruritus in moderate to severe AD, offering a promising treatment option for patients.

Sun Pharma Announces Positive Phase 3 Results for Tildrakizumab in Psoriatic Arthritis

Sun Pharma reveals promising phase 3 results for tildrakizumab (Ilumya) in treating PsA, showing significant symptom improvement in patients.

Remibrutinib Shows Rapid and Sustained Improvement in CSU Activity Score Bands

New findings at Elevate Derm highlight remibrutinib's rapid and sustained efficacy in reducing chronic spontaneous urticaria symptoms, offering hope for patients.

Market, Pharma, and Specialty News

Incyte Awards Spotlight Vitiligo Advocacy and Innovation

Incyte announces the 2024 Ingenuity Awards in Vitiligo recipients, empowering vitiligo advocates and enhancing patient care through innovative initiatives.

VYNE Unblinds Early VYN202 Data After Safety Pause

VYNE Therapeutics updates on VYN202, revealing promising early results in psoriasis treatment despite a clinical hold due to safety concerns.

Jasper Investigates Drug Lot Issue in CSU Study

Jasper Therapeutics reveals promising results from briquilimab trials for chronic spontaneous urticaria, showcasing strong efficacy and safety despite manufacturing challenges.

ILDS, ISD Commemorate World Skin Health Day 2025 With ‘No Health without Skin Health’ Theme

World Skin Health Day 2025 unites global leaders to advocate for skin health equity, emphasizing the urgent need for accessible dermatological care worldwide.

FDA Opens Access to Over 200 CRLs

FDA enhances transparency by publishing over 200 Complete Response Letters, offering insights into drug approval processes and common deficiencies.

Boehringer Ingleheim, LEO Pharma Announce Partnership to Advance Spesolimab in GPP and Beyond

The pharmaceutical companies announced an exclusive global license and transfer agreement for the advancement and commercialization of Spevigo.

Turn Therapeutics Launches Trial for AD Topical GX-03

Turn Therapeutics initiates a groundbreaking clinical trial for GX-03, the first topical IL-36 inhibitor targeting moderate to severe eczema.

FDA Issues CRL for RP1 and Nivolumab in Melanoma

Replimune faces FDA challenges for RP1's approval in advanced melanoma, highlighting complexities in cancer drug development and regulatory scrutiny.

Strides for Skin Health Equity

Q&A Part 2: Reviewing the Significance of Lebrikizumab for Patients With Skin of Color, With Anabela Cardoso, MD

Anabela Cardoso, MD, reflects on specific data from the phase 3b ADmirable trial evaluating the safety and efficacy of lebrikizumab in patients with moderate to severe AD and pigmented skin.

Scalp Disorders in SoC: A Diagnostic Blind Spot

A systematic review reveals critical diagnostic gaps in hair loss treatment for patients with skin of color, urging improved training and protocols in dermatology.

Global Survey Uncovers Misalignment in AD Treatment Guidelines for Pregnant Women

New survey data reveals gaps in atopic dermatitis treatment for pregnant women, highlighting the need for updated guidelines and better physician education.

Women Have Higher Levels of Work and Life Burden Due to Dermatological Conditions Versus Men

New research highlights the significant impact of dermatological diseases on work-life balance, revealing greater burdens for women compared to men.

Claire Fuller, MA, FRCP: WHA Resolution on Skin Diseases Marks a Global Turning Point for Dermatologic Health

A new WHA resolution spotlights skin health, pushing member states to close care gaps and integrate dermatology into public health.

Lars French, MD: Turning Global Skin Health Policy into Action for Patients

Lars French, MD, explains how the new WHA resolution on skin health could drive training, access, and global policy change.

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