Both barzolvolimab doses improved UAS7 at week 12 in EMBARQ-CSU1 and EMBARQ-CSU2, with up to 54% of patients reaching complete response by week 24.
News|Articles|July 29, 2026
Dermatology Times Monthly FDA & Pipeline Review: July 2026
Author(s)Shannon Heaning, Content Associate
July's FDA news was quiet, but an infant AD filing, JAK-refractory alopecia data, and a new device clearance hint at what's next.
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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 designation marks the first FDA Fast Track status granted to a therapy for peeling skin syndrome, which currently has no approved treatment.
LEO Pharma has closed its acquisition of dersimelagon from Tanabe Pharma after the FDA accepted the drug's NDA for filing and granted Priority Review, with a PDUFA date expected by the end of February 2027.
Sol-Gel Technologies has completed patient follow-up in its pivotal phase 3 trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, with top-line results expected in late November 2026.
Two small clinical studies evaluated skincare and dermabrasion for changes in skin quality among individuals taking medical weight loss medications.
The FDA has set a PDUFA target action date of June 29, 2027, based on APEX trial data showing a 65% overall response rate in advanced systemic mastocytosis.
The expanded indication makes Ameluz with RhodoLED the first FDA-approved photodynamic therapy for the treatment of a skin cancer.
Takeda’s investigational oral TYK2 inhibitor is supported by phase 3 LATITUDE data demonstrating significant skin clearance versus placebo and apremilast.
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