
News|Articles|August 31, 2026
Dermatology Times Monthly FDA and Pipeline Review: August 2026
Author(s)Shannon Heaning, Content Associate
Fact checked by: Yasmeen Qahwash
A twice-rejected melanoma immunotherapy finally won accelerated approval, acne's decades-long innovation drought moved a step closer to ending, and 2 rare, sun-triggered skin diseases picked up a deep-pocketed new sponsor.
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Welcome to the Dermatology Times Monthly FDA & Pipeline Review, a recurring look at the regulatory actions and drug development milestones shaping dermatology practice. Each installment tracks approvals, filings, and clinical data readouts against what they mean for patient care, not just what made headlines.
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The novel oral helicase-primase inhibitor demonstrated significantly higher rates of complete lesion healing compared with investigator’s choice treatment in the phase 3 PRIOH-1 trial.

By week 36, combination therapy altered 482 proteins and 467 genes vs 140 and 16 with ixekizumab alone in exploratory TOGETHER-PsO data.

The supplemental New Drug Application seeks to expand the use of Ameluz with red light photodynamic therapy beyond the face and scalp to actinic keratoses on the extremities, neck, and trunk.

The approval of the oral BTKi rests on a phase 3 result of 29.3% complete response from hives vs 14.0% with placebo at week 12.

Celltrion’s US launch of omalizumab-igec adds an interchangeable biosimilar option for eligible patients with chronic spontaneous urticaria.

Prospective data suggest DecisionDx-Melanoma may help refine SLNB decisions and identify recurrence risk beyond conventional staging.

Falk G. Bechara, MD, discusses long-term tunnel control, structural damage, and the evolving role of biologics and surgery in HS care.
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