Latest News and Press Releases

Want to stay updated on the latest news?

Sign into Reader Account Create Reader Account

October 30, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Launches ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5

Arcutis Launches ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Children Ages 2 to 5
October 06, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
September 03, 2025 11:43 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children
June 26, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis’ ZORYVE® (roflumilast) Cream 0.15% Receives Strong Recommendation in American Academy of Dermatology Updated Guidelines for Adult Atopic Dermatitis

The American Academy of Dermatology (AAD) provided evidence-based recommendation for the use of ZORYVE® (roflumilast) cream 0.15% in adults with AD
June 10, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis

The first child has been enrolled in Phase 2 INTEGUMENT-INFANT study evaluating the safety and tolerability of investigational ZORYVE cream for AD
June 06, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis to Present New Long-Term Results of ZORYVE® (roflumilast) Cream at the 2025 Revolutionizing Atopic Dermatitis Conference

Arcutis to present five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, taking place in Nashville, TN, from June 6-7, 2025.
February 28, 2025 09:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis to Present Two Posters at the 83rd American Academy of Dermatology Annual Meeting

Arcutis today announced that it will present two posters at the 2025 AAD annual meeting which will take place in Orlando, FL, from March 7-11, 2025.
February 26, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025
February 24, 2025 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE® (roflumilast) Cream 0.05% in Children 2 to 5 Years Old with Mild to Moderate Atopic Dermatitis in Pediatric Dermatology

Arcutis Announces Publication of Positive Data from INTEGUMENT-PED Trial Evaluating ZORYVE® (roflumilast) Cream 0.05% in Children 2 to 5 Years Old
December 16, 2024 08:00 ET | Source: Arcutis Biotherapeutics, Inc.

Arcutis Submits ZORYVE® (roflumilast) Cream 0.05% Supplemental New Drug Application to the FDA for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis

Arcutis today announced the submission of an sNDA to the FDA for ZORYVE (roflumilast) cream 0.05% for children aged 2 to 5 for mild to moderate AD.