Dermatology

 
FDA Accepts sNDA for Roflumilast Cream 0.05% to Treat Atopic Dermatitis in Children Aged 2 to 5 Years
December 16, 2024

Arcutis Biotherapeutics announced submission of the sNDA today, citing the the supporting positive data from the phase 3 INTEGUMENT-PED and INTEGUMENT-OLE trials.

FDA Approves Nemolizumab for Treatment of Moderate-to-Severe Atopic Dermatitis
December 16, 2024

Nemolizumab is the first approved monoclonal antibody that targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.

Tapinarof Cream, 1%, Gets FDA Green Light for Atopic Dermatitis in Individuals Aged 2 Years and Older
December 16, 2024

Approval for the topical nonsteroidal therapy, based on data from the phase 3 ADORING clinical trial program, helps fill a gap in current offerings for atopic dermatitis.

Expert Perspectives 2024: Nonsteroidal Topicals for Atopic Dermatitis with Mona Shahriari, MD
December 12, 2024

The new nonsteroidal topical treatments for atopic dermatitis are targeted and modify the disease process, explains thought leader Shahriari in this year's video series.

Upadacitinib Safe and Effective for Atopic Dermatitis in Adolescents at 76 Weeks: RCT Analysis
December 11, 2024

Upadacitinib (15 and 30 mg) was evaluated in adolescents with moderate to severe AD aged 12 to 17 years, with and without topical corticosteroids.

Dupilumab Effective for Severe Atopic Dermatitis at 5 Years: Daily Dose
November 07, 2024

Your daily dose of the clinical news you may have missed.

When is It Time to Refer? A Dermatologist Considers Atopic Dermatitis Treated in Primary Care
November 07, 2024

Up to 80% of atopic dermatitis is managed in primary care but some patients will need a higher level of care. Dr Mona Shahriari discusses factors that point to referral.

Nonsteroidal Topical Treatments for Eczema: A Product Snapshot with Mona Shahriari, MD
November 06, 2024

They are a Janus kinase (JAK)1/JAK2 inhibitor, a phosphodiesterase-4 inhibitor, and an investigational aryl hydrocarbon receptor agonist. Learn more about each.

FDA Pushes Back PDUFA Date 3 Months for Tapinarof, 1% Cream for Atopic Dermatitis in Adults and Children
November 05, 2024

The standard 3-month extension is required by the FDA to review what it considered a "major amendment" to the Organon sNDA, ie, new data from ADORING 3.

Dermatologist Mona Shahriari, MD, Talks Nonsteroidal Topicals for Atopic Dermatitis
November 01, 2024

There are 3 classes of nonsteroidal topical therapies for atopic dermatitis that target the specific underlying pathophysiology of the skin disease. Shahriari provides a primer.