Dermatology Times April 2026 Recap
🚨 Clearances, Approvals, Updates, and Recommendations FDA Accepts sNDA for Delgocitinib Cream to Treat Pediatric Chronic Hand Eczema FDA will review LEO Pharma's delgocitinib cream for adolescent patients aged 12-17 with CHE, backed by phase 3 gains and addressing a major treatment gap.
FDA Approves Dupilumab for Chronic Spontaneous Urticaria in Children Aged 2 to 11 The biologic is the first of its kind approved for young children with antihistamine-refractory CSU, expanding an existing indication that previously covered adults and adolescents.
ICYMI: Medicus Pharma Seeks FDA Orphan Drug Designation for SkinJect in Gorlin Syndrome Medicus seeks FDA orphan drug status for SkinJect, a dissolvable microneedle doxorubicin patch targeting Gorlin-related basal cell carcinomas, aiming to reduce the need for repeated surgery.
FDA Issues Complete Response Letter for AbbVie’s Rapid-Onset Neurotoxin, TrenibotulinumtoxinE Potential FDA approval of TrenibotE was delayed due to manufacturing-related issues, with no concerns regarding safety, efficacy, or clinical trial data.
Arcutis Submits sNDA for Roflumilast Cream 0.05% to Treat Atopic Dermatitis in Infants The FDA will review a supplemental New Drug Application for topical roflumilast to treat infant AD with supporting trial data showing rapid itch relief and clear skin gains from week 1.
🧬 Big Studies and Big Data New Data Show Delgocitinib Cream Effective in CHE Before and After Systemic Therapy Among systemic-experienced patients, delgocitinib cream still achieved statistically significant efficacy advantages over cream vehicle across all measured outcomes.
Phase 3 Data Show Upadacitinib Drives Progressive Repigmentation in Non-Segmental Vitiligo Late-breaking data presented at AAD 2026 showed that upadacitinib 15 mg produced statistically significant, progressively improving repigmentation in adults and adolescents with non-segmental vitiligo through 48 weeks.
Real-World Vitiligo Data Reveal High Discontinuation, Low Persistence Across Therapies A retrospective claims analysis found that nearly half of patients newly diagnosed with vitiligo by a dermatologist did not initiate therapy, and those who did showed low persistence across treatment categories.
Cosmo Pharmaceuticals Reports Positive 12-Month Safety Data for Clascoterone 5% in Male AGA Phase 3 data show clascoterone solution sustains hair regrowth for 12 months with vehicle-like safety, paving the way for a novel male androgenetic alopecia option.
Post Hoc Analysis Shows Dupilumab Improves PAS Scores in Patients with Prurigo Nodularis Pooled phase 3 data show dupilumab rapidly reduces prurigo nodularis activity, cuts excoriations, and boosts healing by week 24 versus placebo.
Phase 2b 52-Week Extension Results Demonstrate Sustained Hair Regrowth with Rezpegaldesleukin REZPEG shows growing hair regrowth at 52 weeks in severe alopecia areata, with favorable safety, hinting at a new biologic alternative to JAKs.
Galderma Unveils New Interim Trial Data on Menopause and Weight Loss-Driven Skin Changes Interim investigator-initiated trials reveal how Restylane Skinboosters and Sculptra could improve menopausal skin and address GLP-1 weight-loss volume changes.
ORKA-001 Achieves Complete Skin Clearance in Nearly 2/3 of Psoriasis Patients at Week 16 Interim phase 2a data show ORKA-001, a half-life extended IL-23 inhibitor, achieved complete skin clearance in 63.5% of patients at week 16.
Phase 2/3 Trial of Extended-Release Oral Minoxidil Shows Robust Hair Growth Outcomes in Male Pattern Hair Loss Part A of Study '302' demonstrated statistically significant and clinically meaningful hair growth in men with androgenetic alopecia, with a favorable safety profile and no cardiac adverse events.
🗞 Market, Pharma, and Specialty News Almirall Announces Expanded CVS Caremark Coverage and New Clinical Data for Tirbanibulin at AAD 2026 Christopher Bunick, MD, PhD, and Almirall's Johnny Im discuss new data showing that tirbanibulin 1% ointment provides consistent efficacy, while expanded coverage is poised to improve patient access in the US.
Phase 2b/3 Study Begins for LPP With Brepocitinib LPP affects roughly 100,000 adults in the US and currently has no FDA-approved treatments. Novel Topical Therapy Offers New Path Forward for Oncology-Related Dermatologic Care Hoth Therapeutics has received regulatory approval in Hungary to expand the phase 2 trial into Europe, with Spain and Poland approvals anticipated.
Allergan Aesthetics Invests in Women Business Owners Through Renewed Grant Initiative Applications are now open for Allergan Aesthetics' women's entrepreneurship initiative, which provides coaching, community, and grants of up to $20,000 to qualifying business owners.
The Sun Bus Delivers Screening, Education, and Research on the Road Many participants in the mobile screening program have never previously seen a dermatologist. Sun Pharma to Acquire Organon in $11.75 Billion Deal The deal would vault the combined company to 7th-largest biosimilar player globally, with direct implications for biologic access in dermatology.
💡 Expert Insights How EVO301’s Unique IL-18 Binding Mechanism and Phase 2a Results Could Target Unmet Needs in AD Mark Jackson, MD, of Evommune, provides a therapeutic update on the investigational atopic dermatitis drug, citing strong efficacy and safety after just 2 doses, with phase 2b research on the way.
Previewing NYC’s DermVIP Summit with Founder, Amy Spizuoco, DO, FAOCD The inaugural DermVIP Summit will be held from May 8 to 9 at the New York Academy of Medicine. ODD-SPOT Brings Accessible Skin Cancer Recognition to Patients and Providers The newly published tool, ODD-SPOT, offers a plain-language, photo-supported alternative to the ABCDE criteria, designed to capture the key warning signs of BCC, SCC, and melanoma in accessible terms.
Brepocitinib in Phase 2/3 Trials: A Potential Breakthrough for Lichen Planopilaris Phase 2/3 brepocitinib trial will target moderate to severe LPP, aiming to calm inflammation and symptoms and potentially deliver the first FDA-approved systemic option.
The Cutaneous Connection: Can GLP-1 Therapy Revolutionize Chronic Skin Treatment? In this episode, Daniel Walker, MD, FAAD, explains how GLP-1 drugs may be effective for psoriasis and HS, linking skin inflammation with weight and heart health.
A Legacy of Leadership: A Conversation with Henry W. Lim, MD, FAAD, AAD Gold Medal Recipient Henry W. Lim, MD, FAAD's legacy highlights the impact of mentorship, research, and global advocacy in advancing inclusive dermatologic care and improving skin health worldwide.
5-Star Dermatology Is Built, Not Assumed Kathleen Moe, MD, offers guidance on creating 5-star dermatology patient experience systems for faster access, consistent scripts, and guided checkout that reduce callbacks and build trust.
Could Dupilumab Treat Depression? Mount Sinai Study Targets Immune Link The study represents a repurposing strategy, using dupilumab as a tool compound to probe whether immune-targeted therapy can address a biologically defined subgroup of MDD.
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