5 FDA Approvals in Dermatology: Q2 Recap

During Q2 of 2025, a wide array of developments in the dermatology field have been highlighted by the HCPLive editorial team’s coverage. There were also a variety of US Food and Drug Administration (FDA) decisions that marked Q2 as a time of unique change in the dermatology space.

In this iteration of HCPLive’s end-of-quarter recap summaries, the team highlights some of the most significant decisions by FDA officials related to dermatology treatments in various disease states such as atopic dermatitis, bullous pemphigoid, actinic keratosis, and more. The following list comprises our summary of these notable decisions by the FDA in the dermatology space:

1. FDA Approves Dupilumab (Dupixent) for Bullous Pemphigoid in Adult Patients

Dupilumab's (Dupixent) approval for the treatment of adult patients living with bullous pemphigoid was another significant decision by the FDA in Q2. The June 20, 2025, announcement by Sanofi and Regeneron followed the positive clinical trial data resulting from the ADEPT trial. The decision by FDA officials marks the first targeted drug to be approved, as well as the 8th indication for dupilumab, in a condition with underlying type 2 inflammation.

2. FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis

Roflumilast (Zoryve) foam 0.3% was also approved in Q2 as a once-daily topical treatment for plaque psoriasis in adults and adolescents aged 12 years and older. The foam is a next-generation phosphodiesterase-4 (PDE4) inhibitor, offering a non-steroidal, long-term treatment option for those living with chronic psoriasis. The approval of roflumilast foam 0.3% marks the second approval for this specific formulation of the medication and the fifth indication for roflumilast.

3. FDA Approves New Blue Light Tool for Actinic Keratosis

Premarket application approval (PMA) for use in actinic keratosis was granted by the organization in Q2 for BLU-U Blue Light Photodynamic Therapy (PDT) Illuminators, a model by Sun Pharma featuring light-emitting diode (LED) light panels instead of the fluorescent tubes used in previous models. The new LED BLU-U model, implemented in combination with aminolevulinic acid HCl (KERASTICK) topical solution, 20%, is indicated for the treatment of those with minimally to moderately thick actinic keratoses of the face, scalp, and upper extremities.

4. FDA Approves Pz-cel (Zevaskyn) Gene Therapy for RDEB

Prademagene zamikeracel (Zevaskyn) was approved by FDA officials in Q2 for the treatment of individuals with recessive dystrophic epidermolysis bullosa (RDEB). The announcement was released by Abeona Therapeutics Inc. In the release, prademagene zamikeracel, often referred to as pz-cel, was described as an investigational gene therapy developed for RDEB. The approval is significant as it is the first autologous cell-based gene therapy approved for wounds in adult and pediatric patients with rare, debilitating skin disease. Pz-cel also the first FDA-approved therapy to treat RDEB wounds with a single application.

5. FDA Approves Dupilumab (Dupixent) for Chronic Spontaneous Urticaria

Another significant approval by the FDA in Q2 was that of dupilumab (Dupixent) for the treatment of those aged 12 years and older who live with chronic spontaneous urticaria (CSU). It was specifically indicated for patients in whom CSU is uncontrolled with H1-antihistamines. Regeneron's announcement of the approval follows their positive phase 3 findings in the LIBERTY-CSU CUPID Study A and Study C analyses. These studies had been 24-week, placebo-controlled, randomized studies evaluating dupilumab in CSU.