28 February 2026

February 2026 Dermatology Update: Key FDA Approvals and Treatments

🚨 Clearances, Approvals, Updates, and Recommendations

The FDA has officially accepted Galderma’s Biologics License Application (BLA) resubmission for relabotulinumtoxinA, commercially known as Relfydess. This innovative liquid neuromodulator is poised to transform the landscape of wrinkle treatments by delivering rapid results that last, although final approval from the FDA is still pending.

Meanwhile, AbbVie has submitted a request for FDA and EMA approval for upadacitinib, a prospective breakthrough systemic therapy aimed at treating non-segmental vitiligo in both adults and adolescents. This indication could significantly enhance treatment options for patients dealing with this skin condition.

In China, Almirall’s sarecycline has received approval from the NMPA, marking a significant advancement in oral treatments for moderate to severe acne. This approval is expected to improve patient access to effective acne therapies, ultimately enhancing clinical outcomes.

The FDA has recently updated the iPLEDGE REMS program concerning isotretinoin for acne treatment. The new modifications include allowances for certain at-home pregnancy tests and a reduction in the number of lockouts, which should alleviate some of the administrative challenges previously faced by healthcare providers.

In another significant development, Biofrontera has submitted a supplemental new drug application to the FDA for its Ameluz photodynamic therapy aimed at treating superficial basal cell carcinoma (sBCC). A decision from the FDA on this application is anticipated by September 28, 2026.

In case you missed it, a pivotal study has shown that significantly more patients achieved clear or nearly clear skin after just four weeks of using difamilast ointment twice daily, as compared to a vehicle treatment. This expansion of non-steroidal options in managing atopic dermatitis (AD) could provide new avenues for patient care.

🧬 Big Studies and Big Data

In promising research outcomes, Arcutis has unveiled phase 2 data demonstrating the efficacy of roflumilast cream in treating infants with atopic dermatitis. The results indicate both safety and potential effectiveness, which could lead to new treatment protocols for this vulnerable population.

Additionally, Sagimet and Ascletis have reported positive safety and efficacy data from a 52-week study on denifanstat, a once-daily oral FASN inhibitor for acne. This data underscores sustained improvements in acne management.

A study published in JAAD validates the 487-GEP test, which assists in guiding the selection of JAK inhibitors for patients with moderate to severe AD. The test stratifies patients based on their molecular profiles, identifying those who are more likely to respond positively to JAK treatments compared to Th2-targeted therapies.

In the phase 3b TOGETHER-PsO trial, a combination of ixekizumab and tirzepatide outperformed biologic monotherapy, showing significantly higher rates of complete skin clearance and achieving ≥10% weight loss.

UCB has presented three-year results from the BE HEARD trial for bimekizumab in treating moderate-to-severe hidradenitis suppurativa (HS). The data indicates sustained lesion clearance and significant reductions in overall severity.

The phase 2 BEACON trial has demonstrated that brepocitinib is effective in rapidly clearing lesions of cutaneous sarcoidosis, with strong gains in the CSAMI metric and good tolerability. Priovant is preparing to advance into a phase 3 program based on these findings.

The REZOLVE-AD trial indicates that rezpegaldesleukin provides durable control of atopic dermatitis with monthly or quarterly dosing schedules, supporting Nektar’s plans for phase 3 studies.

In an innovative approach, Septerna will present phase 1 results on SEP-631 at the upcoming AAAAI conference, focusing on targeting MRGPRX2 to manage mast cell flares and broaden treatment options for refractory chronic spontaneous urticaria (CSU).

A recent meta-analysis supports the efficacy of 308 nm excimer laser treatments for plaque psoriasis, showing consistent clinical improvements following twice-weekly sessions.

Novartis has announced that remibrutinib has successfully met its primary endpoints in the phase 3 trial for chronic inducible urticaria subtypes. The company has submitted a supplemental New Drug Application to the FDA for treating symptomatic dermographism.

🗞 Market, Pharma, and Specialty News

A new platform, Dermatology Times NP/PA Connect, has been launched to provide educational resources, community support, and professional growth opportunities tailored to dermatology nurse practitioners (NPs) and physician assistants (PAs), aimed at enhancing patient care.

Aminex Therapeutics has initiated a phase 1b/2 trial evaluating the inhibition of the polyamine pathway in patients with metastatic melanoma and breast cancer. This study has significant implications for dermatologists managing advanced melanoma cases.

During the recent Super Bowl, viewers caught a glimpse of various health and dermatology-related commercials, reminding audiences of the importance of skin health awareness and access to treatments.

On Rare Disease Day, industry insights were shared regarding pipeline updates in conditions like epidermolysis bullosa, which affects approximately 6.8 million people globally, among other rare skin diseases.

The PDPA 2025 compensation survey, led by president Jamie Restivo, PA-C, has provided key insights into dermatology PA pay trends, productivity bonuses, benefits disparities, and factors influencing job satisfaction and retention.

Alphyn Biologics is advancing zabalafin hydrogel into a phase 2 trial for treating molluscum contagiosum. The goal is to provide painless relief for pediatric patients by effectively clearing lesions and alleviating itch.

⚖️ Strides for Skin Health Equity

Recent findings suggest that fractional CO₂ resurfacing is effective in reducing acne scarring in patients with darker skin types, balancing both safety and efficacy in treatment.

On World Cancer Day 2026, La Roche-Posay and the Oncology Nursing Society collaborated to launch a pioneering Skin of Color Toxicity Repository, aimed at improving cancer care for patients with diverse skin tones.

Dr. Cheri Frey emphasizes a pigment-first approach to anti-aging strategies for skin of color, advocating for safer lasers, peels, and techniques to prevent post-inflammatory hyperpigmentation (PIH).

New phase 3 data from the DISCREET trial supports the long-term use of apremilast in managing symptoms of genital psoriasis, showing improvements in itch, skin clearance, and overall sexual quality of life over 32 weeks.

This issue highlights advancements in equity, precision, and awareness in dermatology, focusing on clinical insights that are particularly relevant for inflammatory skin conditions across diverse populations.

A recent study has linked depression with an immune signature associated with atopic dermatitis, revealing overlaps in blood immune profiles among patients with depression and inflammatory skin diseases. This finding points to the Th2 axis as a potential target for future treatments.

In a compelling discussion, Dr. Joni Jefferson sheds light on representation, patient education, and the importance of mentorship in skin of color dermatology, particularly in the context of aesthetic medicine during Black History Month.