Arcutis Biotherapeutics has secured U.S. Food and Drug Administration acceptance of its supplemental New Drug Application for Zoryve roflumilast cream 0.05 percent to expand treatment of mild to moderate atopic dermatitis to infants aged 3 to 24 months. The filing moves the steroid-free topical therapy into a regulatory review with a target action date of
AbbVie has secured a broad pediatric label for Skyrizi, adding both plaque psoriasis and active psoriatic arthritis alongside a new dose for children weighing less than 40 kg. The approval could strengthen treatment choice, although the evidence supporting the two indications is not equally direct.
Can ZORYVE cream transform infant eczema care? Explore what this FDA filing means for non-steroidal treatment strategies today.
Galderma's nemolizumab phase II data in children aged 2-11 show 52-week itch and lesion relief. Read the analysis.
FDA approves Novartis Cosentyx for adolescent hidradenitis suppurativa. Discover what this decision means for biologic treatment strategies.
Arcutis Biotherapeutics takes full control of ZORYVE promotion. See how this shift could affect real-world dermatology and pediatric prescribing.
Alphyn Biologics has secured $25 million in a twice-oversubscribed Series B financing round to support its clinical pipeline for dermatologic conditions. The funding will enable the company to advance a global Phase 2b trial of its lead asset, Zabalafin Hydrogel, for atopic dermatitis, while also launching a second Phase 2 program for molluscum contagiosum virus.