5 Dermatology Approvals to Know from the First Half of 2026

The first half of 2026 has unfolded during a period of steady momentum in dermatology.

From expanding pediatric access to systemic therapies to the arrival of the first new sunscreen chemistry in decades, the specialty has seen regulatory action that reaches across age groups and disease states. Even as clinicians navigate a crowded biologic and small-molecule landscape, the US Food and Drug Administration (FDA) has continued to clear approvals in 2026 that extend existing therapies to underserved populations and introduce genuinely new options to the armamentarium.

This year has already brought forward decisions that could reshape care for children and adults alike. From the first oral IL-23 receptor blocker for plaque psoriasis, to a biologic reaching chronic spontaneous urticaria sufferers as young as 2, dermatology's first half of 2026 combines mechanistic novelty with meaningful expansions of access. Meanwhile, a steroid-free topical now reaches toddlers with psoriasis, an IL-23 inhibitor extends into pediatric psoriatic arthritis, and the sunscreen aisle is poised for its biggest shake-up in a generation.

These 5 approvals, listed below in chronological order, span new mechanisms, expanded pediatric indications, and a first-of-its-kind sunscreen ingredient, reflecting the range of regulatory activity dermatology has seen in the first half of 2026.

5 Dermatology Approvals to Know from the First Half of 2026

1. FDA Approves Icotrokinra, First Oral IL-23 Receptor Blocker for Psoriasis

Date: March 18, 2026
Indication: Moderate-to-Severe Plaque Psoriasis
Company: Johnson & Johnson
Summary: On March 18, 2026, the FDA approved icotrokinra (Icotyde), a first-in-class oral IL-23 receptor antagonist, for moderate-to-severe plaque psoriasis in adults and adolescents 12 years and older weighing at least 40 kg. Unlike existing IL-23 inhibitors that target the cytokine itself, the once-daily oral peptide selectively blocks the IL-23 receptor, and the ICONIC phase 3 program—spanning roughly 2,500 patients—included head-to-head data against the active oral comparator deucravacitinib as well as evaluation in high-impact sites like scalp and genital psoriasis. According to Johnson & Johnson, the drug combines skin clearance with a favorable safety profile in a once-daily pill. This approval marks the first oral option in a psoriasis treatment landscape long dominated by injectable biologics.¹

2. FDA Approves Dupilumab for Chronic Spontaneous Urticaria in Children Aged 2 to 11

Date: April 22, 2026
Indication: Chronic Spontaneous Urticaria
Company: Sanofi/Regeneron
Summary: On April 22, 2026, the FDA approved dupilumab (Dupixent) for children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy, making it the first biologic authorized in the US for this age group. The decision extends a prior approval that covered adults and adolescents 12 and older, and is supported by the LIBERTY-CUPID trial program along with pharmacokinetic data from the pediatric CUPIDKids study. According to Sanofi and Regeneron, the approval addresses a significant treatment gap for children who previously had no options beyond antihistamines. This approval brings a targeted, IL-4/IL-13-blocking option to more than 14,000 US children estimated to have antihistamine-refractory CSU.²

3. FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis

Date: June 26, 2026
Indication: Plaque Psoriasis and Psoriatic Arthritis
Company: AbbVie
Summary: On June 26, 2026, the FDA approved risankizumab-rzaa (Skyrizi) for children aged 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for pediatric patients 6 years and older with active psoriatic arthritis. The approval adds a new 55-mg prefilled syringe to support weight-based dosing in patients weighing less than 40 kg, and is supported by the phase 3 OptIMMize psoriasis program, which reported clinically meaningful improvements in PASI and static Physician Global Assessment scores maintained through continued treatment. The pediatric psoriatic arthritis indication relies on the psoriasis efficacy data combined with population pharmacokinetic modeling from adult psoriatic arthritis studies rather than a dedicated pediatric arthritis trial. This approval makes risankizumab the first IL-23 inhibitor approved in the US for pediatric patients under 40 kg with either condition.³

4. FDA Expands Sunscreen Options with First New Active Ingredient in 20 Years

Date: June 9, 2026
Indication: Broad-Spectrum UV Protection
Company: DSM-Firmenich
Summary: On June 9, 2026, the FDA finalized the addition of bemotrizinol to the over-the-counter sunscreen monograph, marking the first new active sunscreen ingredient added in the US since the late 1990s. Approved for use at concentrations up to 6% in adults and children 6 months and older, bemotrizinol provides broad-spectrum protection against both UV-A and UV-B rays, has shown low levels of skin absorption, and is the first chemical-based filter to receive the agency's generally recognized as safe and effective (GRASE) designation. The ingredient, long available in Europe and other markets, was cleared through the streamlined administrative order process established by the CARES Act, with the FDA finalizing action within seven months of its proposed order. This approval is expected to expand formulation options for patients seeking lighter-textured, high-UVA-protection sunscreens.⁴

5. FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis Down to Age 2

Date: June 29, 2026
Indication: Plaque Psoriasis
Company: Arcutis Biotherapeutics
Summary: On June 29, 2026, the FDA approved an expanded indication for roflumilast cream 0.3% (Zoryve), extending its use in plaque psoriasis, including intertriginous areas, to children as young as age 2. The approval was based on a four-week Maximal Usage Systemic Exposure study and supportive long-term safety data from a 24-week open-label extension study in children aged 2 to 5, and removes prior restrictions on duration of use. Per Arcutis, the topical PDE4 inhibitor was safe and well-tolerated in children as young as 2, giving physicians and caregivers a targeted therapy usable anywhere on the body for any duration. This approval makes roflumilast cream 0.3% the first once-daily, steroid-free topical treatment approved for plaque psoriasis in this age group.⁵

References:

1. Hebebrand M. FDA approves icotrokinra, first oral IL-23 receptor blocker for psoriasis. Dermatology Times. Published March 18, 2026. Accessed July 10, 2026. https://www.dermatologytimes.com/view/fda-approves-ictrokinra-first-oral-il-23-receptor-blocker-for-psoriasis

2. Hebebrand M. FDA approves dupilumab for chronic spontaneous urticaria in children aged 2 to 11. Dermatology Times. Published April 27, 2026. Accessed July 10, 2026. https://www.dermatologytimes.com/view/fda-approves-dupilumab-for-chronic-spontaneous-urticaria-in-children-aged-2-to-11

3. Johnson V. FDA approves risankizumab for pediatric plaque psoriasis, psoriatic arthritis. HCPLive. Published June 26, 2026. Accessed July 10, 2026. https://www.hcplive.com/view/fda-approves-risankizumab-pediatric-plaque-psoriasis-psoriatic-arthritis

4. US Food and Drug Administration. FDA expands sunscreen options for the first time in 20 years. News release. FDA. Published June 9, 2026. Accessed July 10, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years

5. Bader K. FDA approves roflumilast cream 0.3% for plaque psoriasis down to age 2. Dermatology Times. Published June 29, 2026. Accessed July 10, 2026. https://www.dermatologytimes.com/view/fda-approves-roflumilast-cream-0-3-for-plaque-psoriasis-down-to-age-2