7 Dermatology Headlines You Missed in September 2026

September brought a busy stretch of regulatory activity in dermatology, including 2 US Food & Drug Administration (FDA) approvals and 2 accepted applications spanning alopecia areata, rare photodermatoses, systemic mastocytosis, and skin cancer. The month closed with head-to-head phase 3 psoriasis data at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna. Here is a look back at 7 stories dermatologists may have missed.

FDA Approvals and Regulatory Updates in Dermatology

FDA Approves Baricitinib for Adolescents With Severe Alopecia Areata

On September 25, the FDA approved Eli Lilly's baricitinib (Olumiant) for patients aged ≥ 12 years with severe alopecia areata, expanding the oral JAK inhibitor's 2022 adult indication. Approval was based on 36-week data from the phase 3 BRAVE-AA-PEDS trial, in which 42% of adolescents receiving 4 mg and 27% receiving 2 mg achieved a Severity of Alopecia Tool (SALT) score of ≤ 20, compared with 5% receiving placebo. Lilly reported a safety profile consistent with that observed in adults.

Ameluz Treatment Becomes First FDA-Approved PDT for Skin Cancer

On September 14, the FDA approved Biofrontera's aminolevulinic acid hydrochloride topical gel, 10% (Ameluz), with the BF-RhodoLED lamp series for superficial basal cell carcinoma (sBCC) in adults, making it the first photodynamic therapy (PDT) regimen cleared for a skin malignancy. In a phase 3 trial of 187 adults, 66% of patients receiving Ameluz PDT achieved composite clinical and histological complete response at 12 weeks, compared with 5% receiving placebo-PDT. Biofrontera plans to launch the sBCC indication between late Q4 2026 and Q1 2027.

Read more: Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

Dersimelagon Gains FDA Priority Review for EPP, XLP

The FDA accepted and granted priority review to the new drug application (NDA) for dersimelagon, an investigational oral melanocortin 1 receptor agonist for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), with a PDUFA date set for the end of February 2027. No oral therapy is currently approved for either condition. In the phase 3 INSPIRE trial (N = 165), dersimelagon produced a placebo-adjusted increase of approximately 23 minutes in sunlight exposure time to the first prodromal symptom during weeks 12 through 16 (P = .004).

FDA Accepts Bezuclastinib NDA for Advanced Systemic Mastocytosis

The FDA accepted Cogent Biosciences' NDA for bezuclastinib, a selective KIT D816V inhibitor, in adults with advanced systemic mastocytosis, setting a PDUFA date of June 29, 2027. In the pivotal APEX trial, bezuclastinib achieved an overall response rate of 65% by modified IWG-MRT-ECNM criteria, with 12-month progression-free and overall survival rates of 79% and 87%, respectively. Separate bezuclastinib filings in gastrointestinal stromal tumors and nonadvanced systemic mastocytosis carry PDUFA dates of November 30 and December 30, 2026.

Phase 3 Trial Data in Psoriasis

EADV 2026: Zasocitinib Tops Deucravacitinib for PASI 100 in Plaque Psoriasis

In the phase 3 LATITUDE Atlas trial, a head-to-head comparison of 2 oral TYK2 inhibitors in 606 adults with moderate to severe plaque psoriasis, 36.5% of patients receiving zasocitinib 30 mg achieved PASI 100 at week 16, compared with 13.9% receiving deucravacitinib 6 mg (P < .001). Zasocitinib also outperformed deucravacitinib on PASI 90 (62.5% vs 34.0%) and static Physician Global Assessment score of 0 (43.2% vs 18.5%). The FDA accepted Takeda's NDA for zasocitinib under priority review in September 2026.

Feature: Precision Medicine in Dermatology

Where is Precision Medicine Today in Dermatology?

Precision medicine has become a recurring theme at major dermatology meetings, though clinicians remain divided on how close the field is to applying it in routine care. In this feature, HCPLive asked several dermatology leaders how far the specialty has come and where precision approaches are headed next.

Dermatology Conference Recap: LEADderm 2026

LEADderm 2026 Recap: 7 Interviews Dermatologists Should Know

LEADderm 2026 in Newport Beach, California, centered on skills clinical training often overlooks, including mentorship, negotiation, and practice management. HCPLive's recap gathers 7 on-site interviews covering molluscum contagiosum care, hidradenitis suppurativa pipeline data, precision medicine, and dermatology leadership.