Dermatology Times 2025 Year in Review: Drug Approvals

The year 2025 has marked a remarkable period of innovation in dermatology, with the FDA granting approvals for a wide range of therapies spanning chronic inflammatory skin diseases, rare genetic disorders, and oncology. These approvals reflect significant advancements in targeted treatments, biologics, gene therapy, and device-based interventions, offering clinicians new tools to address previously unmet medical needs. From novel JAK and PDE4 inhibitors to the first gene therapy for recessive dystrophic epidermolysis bullosa, this wave of approvals demonstrates the accelerating pace of therapeutic development and the expansion of options for both adult and pediatric patients.

2025 Approvals

April 18: Dupilumab for Adolescents and Adults With H1 Antihistamine–Refractory CSU

The FDA approved dupilumab (Dupixent; Regeneron Pharmaceuticals and Sanofi) for the treatment of chronic spontaneous urticaria (CSU) in patients 12 years and older who remain uncontrolled on H1 antihistamines—the first new targeted therapy for CSU in more than a decade. The approval was supported by data from the phase 3 LIBERTY-CSU CUPID (NCT04180488) study program, in which dupilumab significantly improved itch and hive severity and nearly doubled rates of well-controlled disease compared with placebo.¹

April 29: First Gene Therapy for RDEB

Prademagene zamikeracel (pz-cel; Zevaskyn; Abeona Therapeutics), the first autologous, cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), was approved in April, marking a major advance in regenerative dermatology.Data from the phase 3 VIITAL study (NCT04227106) demonstrated significant and sustained wound closure, lasting up to 8 years in some patients, with a favorable long-term safety profile.²

May 16: LED BLU-U Device for AK

In May, the FDA approved Sun Pharmaceutical’s next-generation LED BLU-U Blue Light Photodynamic Therapy Illuminator for use with aminolevulinic acid hydrochloride 20% (Levulan Kerastick) in treating minimally to moderately thick actinic keratoses (AKs) on the face, scalp, and upper extremities. The updated model replaces fluorescent tubes with LED technology, offering improved light uniformity, a compact 5-panel design, and enhanced ergonomic functionality while maintaining the same clinical mechanism: photoactivation of aminolevulinic acid to induce localized cytotoxic effects and lesion clearance.³

May 22: Roflumilast Foam for Plaque Psoriasis

The approval of roflumilast 0.3% foam (Zoryve; Arcutis Biotherapeutics) for plaque psoriasis of the scalp and body in patients 12 years and older came in 2025, marking the first and only branded topical foam for psoriasis. This once-daily, steroid-free PDE4 inhibitor offers rapid symptom relief, with pivotal trials (phase 3 ARRECTOR (NCT05028582)) demonstrating that up to 63% of patients achieved significantly clear skin by 8 weeks, along with early itch improvement within 24 hours. The foam formulation is designed for hair-bearing and sensitive areas, minimizing irritants while maintaining high potency, and is generally well tolerated.⁴

June 20: Dupilumab for Bullous Pemphigoid

Also approved in 2025, dupilumab (Dupixent; Regeneron Pharmaceuticals and Sanofi) for the treatment of adults with bullous pemphigoid represented the first targeted therapy for this autoimmune blistering disease. The approval was based on results from the phase 2/3 LIBERTY-BP (NCT04206553) trial, in which dupilumab plus tapering oral corticosteroids led to higher rates of sustained disease remission (18.3% vs 6.1% with placebo), meaningful itch reduction (38.3% vs 10.5%), and reduced cumulative corticosteroid use over 36 weeks.⁵

July 23: Delgocitinib for Adults With Moderate to Severe CHE

Another groundbreaking approval was for delgocitinib cream (Anzupgo; LEO Pharma), representing the first treatment for adults with moderate to severe chronic hand eczema (CHE) who have not responded to topical corticosteroids or for whom steroids are unsuitable. This topical pan-JAK inhibitor demonstrated efficacy in the phase 3 DELTA 1 (NCT04871711) and DELTA-2 trials (NCT04872101), with 20% to 29% of patients achieving clear or almost clear skin vs 7% to 10% on vehicle, along with meaningful reductions in pain and itch. Long-term data from the DELTA 3 (NCT04949841) extension showed durable responses, favorable tolerability, and rapid recapture of disease control upon retreatment.⁶

September 18: Ruxolitinib Cream for Pediatric AD

In 2025, the FDA approved ruxolitinib cream (Opzelura; Incyte) for children aged 2 to 11 years with mild to moderate atopic dermatitis (AD), making it the first topical JAK inhibitor available for this pediatric population. The approval was supported by the phase 3 TRuE-AD3 (NCT04921969) trial, in which ruxolitinib cream demonstrated significant efficacy, with Investigator Global Assessment treatment success achieved in 36% to 57% of patients vs 11% with vehicle, rapid itch relief within 2 weeks, and improvements in quality-of-life measures.⁷

September 29: Guselkumab for Pediatric PsO and PsA

In 2025, guselkumab (Tremfya; Johnson & Johnson) received FDA approval for children 6 years and older (≥ 40 kg) with moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA), marking the first pediatric approval of an IL-23 inhibitor for these conditions. The decision was supported by the phase 3 PROTOSTAR (NCT03451851) study, in which guselkumab demonstrated high efficacy, with 56% of patients achieving 90% improvement in the Psoriasis Area and Severity Index and nearly 40% achieving complete skin clearance at week 16 compared with 16% and 4% for placebo, respectively.⁸

September 30: Remibrutinib for CSU

In September, the FDA approved remibrutinib (Rhapsido; Novartis), an oral Bruton tyrosine kinase inhibitor (BTKi), for adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamines, marking the first BTKi approved for this condition. Phase 3 REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials showed rapid and significant improvements in itch, hives, and urticaria activity scores, with approximately one-third of patients achieving complete symptom resolution by week 12.⁹

October 6: Roflumilast for AD as Young as 2 Years

Kicking off October, the FDA gave the green light to roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) for children aged 2 to 5 years with mild to moderate atopic dermatitis, offering a steroid-free, once-daily topical treatment for long-term management of pediatric eczema. Clinical trials (INTEGUMENT-PED (NCT04845620) and INTEGUMENT-OLE (NCT04804605)) demonstrated rapid improvement in eczema severity and itch, with approximately 40% of children achieving a 75% reduction in disease signs and more than one-third reporting meaningful itch relief within 4 weeks.¹⁰ 

October 13: Cemiplimab as Adjuvant Immunotherapy for High-Risk CSCC

Finally, the FDA granted approval to cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) as an adjuvant therapy for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, marking the first immunotherapy authorized in this setting. The approval is supported by phase 3 C-POST (NCT03969004) trial data, which showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo, with 24-month disease-free survival rates of 87.1% vs 64.1% and significant reductions in locoregional and distant recurrence.¹¹

Conclusion

The 2025 FDA approvals underscore a transformative year in dermatologic care, introducing therapies that not only improve symptom control but also expand the possibilities for long-term disease management and patient quality of life. With the first targeted treatments for conditions such as bullous pemphigoid, chronic hand eczema, and pediatric psoriasis, alongside innovative gene and immunotherapies, clinicians now have a broader armamentarium to personalize care. These developments highlight the ongoing shift toward precision dermatology, signaling a future where more patients can achieve meaningful disease control with safer, more effective, and tailored interventions.

References

1. Dupixent (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU). News release. Regeneron Pharmaceuticals. April 18, 2025. Accessed November 10, 2025. https://www.globenewswire.com/news-release/2025/04/18/3064133/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-New-Targeted-Therapy-in-Over-a-Decade-for-Chronic-Spontaneous-Urticaria-CSU.html
2. US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB). News release. Abeona Therapeutics. April 29, 2025. Accessed November 10, 2025. https://investors.abeonatherapeutics.com/press-releases/detail/303/u-s-fda-approves-zevaskyn-prademagene-zamikeracel
3. Sun Pharma announces FDA approval of next generation BLU-U Blue Light Photodynamic Therapy Illuminator for actinic keratosis. News release. Sun Pharma. May 16, 2025. Accessed November 10, 2025. https://www.prnewswire.com/news-releases/sun-pharma-announces-fda-approval-of-next-generation-blu-u-blue-light-photodynamic-therapy-illuminator-for-actinic-keratosis-302457770.html
4. Arcutis’ Zoryve (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. News release. Arcutis Biotherapeutics. May 22, 2025. Accessed November 10, 2025. https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/
5. Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid. News release. Sanofi. June 20, 2025. Accessed November 10, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-20-05-00-00-3102518
6. Anzupgo (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News release. LEO Pharma. July 23, 2025. Accessed November 10, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults
7. Incyte announces additional FDA approval of Opzelura (ruxolitinib) cream in children ages 2-11 with atopic dermatitis. News release. Incyte. September 18, 2025. Accessed November 10, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib
8. US FDA approves Tremfya (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor. News release. Johnson & Johnson. September 29, 2025. Accessed November 10, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-for-the-treatment-of-pediatric-plaque-psoriasis-and-active-psoriatic-arthritis-marking-a-first-and-only-approval-for-an-il-23-inhibitor
9. Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Accessed November 10, 2025. https://www.globenewswire.com/news-release/2025/09/30/3159065/0/en/Novartis-receives-FDA-approval-for-Rhapsido-remibrutinib-the-only-oral-targeted-BTKi-treatment-for-chronic-spontaneous-urticaria-CSU.html
10. FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5. News release. Arcutis Biotherapeutics. October 6, 2025. Accessed November 10, 2025. https://www.globenewswire.com/news-release/2025/10/06/3161656/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html
11. Libtayo (cemiplimab-rwlc) approved in the US as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (CSCC) with a high risk of recurrence after surgery and radiation. News release. Regeneron Pharmaceuticals. October 8, 2025. Accessed November 10, 2025. https://investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-rwlc-approved-us-first-and-only