Lutikizumab significantly improved HiSCR75 response, pain, and disease flares in adults and adolescents with moderate to severe HS.
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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Disc Medicine reports the phase 3 APOLLO trial met all primary and secondary end points, with whole-blood PPIX reduced 41.4% vs placebo and an NDA resubmission planned by end of 2026.
The FDA clearance allows Edesa to expand an ongoing placebo-controlled study of the CXCL10 antibody EB06 to US sites, with topline data expected in the fourth quarter of 2027.
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.
Shannon Trotter, DO, moderated a Dermatology Times Case-Based Roundtable event on how pharmacokinetics, adverse event timing, and trial response criteria should shape hedgehog pathway inhibitor selection in advanced BCC.
Cosibelimab-ipdl is now an NCCN Category 2A option for locally advanced CSCC in patients ineligible for curative surgery or radiation.
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