8 Dermatology Headlines You Missed in September 2025

In September 2025, a wide range of developments have transpired in the field of dermatology, including new research into dermatologic disease states and approvals of medications such as remibrutinib and guselkumab by the US Food and Drug Administration (FDA).

These developments, along with the occurrence of the European Academy of Dermatology and Venereology (EADV) Congress in Paris, made September a uniquely eventful month in the dermatology space. In this summary of notable dermatology headlines in the month of September, we cover an array of developments in skin health news, though HCPLive’s September coverage of EADV is included in a separate summary.

The following list of September dermatology headlines worth exploring among clinicians highlights non-conference coverage:

FDA Approves Remibrutinib for Chronic Spontaneous Urticaria

Remibrutinib (Rhapsido), a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, was approved by the FDA in September for the treatment of adults with chronic spontaneous urticaria (CSU). This approval of Novartis’s drug was announced on September 30 and allows patients with CSU to have access to an alternative, oral option, provided their symptoms remain uncontrolled despite the use of antihistamines.

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

Johnson & Johnson’s guselkumab (Tremfya) was also approved in September for children ≥ 6 years of age who also weigh ≥ 40 kg (88 lbs) and live with moderate to severe plaque psoriasis (PsO). Those who qualify, according to the announcement, are candidates for systemic therapy or phototherapy. Following this decision, guselkumab became the first and only interleukin (IL)-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020.

FDA Approves Ruxolitinib Cream for Pediatric Patients with Atopic Dermatitis

On September 18, the Incyte Corporation’s ruxolitinib cream (OPZELURA) was approved by the FDA for the treatment of children aged 2 - 11 years with moderate-to-severe atopic dermatitis. Ruxolitinib cream was indicated in this approval for atopic dermatitis in the short-term and for non-continuous chronic treatment among children who are non-immunocompromised and aged ≥ 2 years. Those qualified will have had disease that is not well controlled with topical prescription drugs, or when those drugs are not recommended. This approval decision follows the phase 3 TRuE-AD3 trial.

FDA Approves Beremagene Geperpavec-svdt (Vyjuvek) Label Update in DEB

In another approval announcement in September, Krystal Biotech’s label update for beremagene geperpavec-svdt (Vyjuvek) expanded the drug’s eligible patient population to include individuals with dystrophic epidermolysis bullosa (DEB) from the time of birth. This update provides those with this condition full flexibility with respect to beremagene geperpavec-svdt application and the management of wound dressings, given that patients are now permitted to remove as part of the next dressing change instead of waiting 24 hours.

Maternal Dietary Diversity Associated with Decreased Childhood Eczema Risk

A decreased risk of atopic dermatitis development was linked in a September study with increased maternal dietary diversity during the pregnancy period. Yang-Ching Chen, MD, PhD, from the School of Nutrition and Health Sciences at Taipei Medical University, authored this research along with a series of other investigators. The team implemented the Taipei Mother–Infant Nutrition Cohort, a population-based study following 2337 mother–infant pairs, for their research.

Biologic Therapy is Associated with Reduced Risk of Malignancy in Psoriasis

Another study from September identified an association between treatment of psoriasis with biologic drugs and a significant reduction in the risk of malignancy among patients, compared to topical monotherapies. Investigators in Japan had sought to expand upon the lack of research on the long-term impacts of biologics on patients’ risk of malignancy for those living with psoriasis. It was authored by such investigators as Saori Takamura, from the Saitama Medical Center Department of Dermatology in Japan.

Topline Results Announced on Rocatinlimab for Adults with Atopic Dermatitis

Preliminary ASCEND trial findings released in September suggest that rocatinlimab therapy offers sustained improvements in skin clearance and itch for individuals with moderate to severe atopic dermatitis. These data also showed that the drug maintained a favorable long-term safety profile and low rates of discontinuation. There were nearly 2600 participants involved in this study, with long-term efficacy and safety over 104 weeks being evaluated and dosing taking place every 4 or 8 weeks.

Narrowband-UVB Phototherapy Effective for Psoriasis in Skin of Color

In another study from September, narrowband-ultraviolet B (NB-UVB) phototherapy was shown to be an effective alternative therapy for individuals with skin of color who have psoriasis and have failed topical drug regimens. This study was authored by such investigators as Mio Nakamura, MD, from the Department of Dermatology at the University of Michigan, Ann Arbor. In this systematic review, NB-UVB phototherapy was assessed, with the research team highlighting that NB-UVB may be helpful for those with multiple comorbidities or those seeking alternatives to systemics or biologics.