Showing 11-16 of 16 results for "".
- Zoryve from Arcutis Approved for Plaque Psoriasishttps://practicaldermatology.com/news/zoryve-from-arcutis-approved-for-plaque-psoriasis/2461282/FDA has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% from Arcutis Biotherapeutics for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and only topical phosphodiesterase-4 (PDE4) inhibitor approved fo…
- FDA Accepts Arcutis Biotherapeutics’ NDA for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasishttps://practicaldermatology.com/news/fda-accepts-arcutis-biotherapeutics-nda-for-roflumilast-cream-for-adults-and-adolescents-with-plaque-psoriasis/2461018/The FDA accepted Arcutis Biotherapeutics’ new drug application (NDA) for roflumilast cream for the treatment of psoriasis in adults and adolescents. The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022. “With the FDA commencing a review of o…
- New Survey Reveals Negative Impact of Psoriasis on Mental Healthhttps://practicaldermatology.com/news/new-survey-reveals-negative-impact-of-psoriasis-on-mental-health/2461159/Arcutis Biotherapeutics, Inc. recently shared findings from the Skin Insights: Uncovering Psoriasis Survey, a national survey of 507 adults 18+ diagnosed with plaque psoriasis who are on topical treatments. The online survey was conducted by The Harris Poll and was designed to reveal insights into …
- Early Study Demonstrates Roflumilast cream Safe and Effective for Chronic Plaque Psoriasishttps://practicaldermatology.com/news/early-study-demonstrates-roflumilast-cream-safe-and-effective-for-chronic-plaque-psoriasis/2460493/Arcutis Biotherapeutics, Inc. shared positive results from a Phase 1/2a trial of its investigational drug topical roflumilast cream for the treatment of chronic plaque psoriasis that were published in the August issue of the Journal of Drugs in Dermatology. The results demonstrate that ARQ-151 (rof…
- Arcutis Submits NDA for Roflumilast Cream 0.15% for AD Treatmenthttps://practicaldermatology.com/news/arcutis-submits-nda-for-roflumilast-cream-015-for-ad-treatment/2462001/Arcutis Biotherapeutics, Inc. submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older. Roflumilast cream is a once-dail…
- Promising and Consistent Topline Results Seen in Phase 3 Trial of Roflumilast in ADhttps://practicaldermatology.com/news/promising-and-consistent-topline-results-seen-in-phase-3-trial-of-roflumilast-in-ad/2461466/Arcutis Biotherapeutics, Inc.’s roflumilast met the key primary and secondary endpoints in the INTEGUMENT-2 pivotal Phase 3 trial of , adults and children 6 years and older with mild to moderate atopic dermatitis (AD). The new findings are consistent with positive topline results from the INTEGU…
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