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Clinical commentary, education, and community stories from across the Alliance.

FDA Approves ZORYVE® (roflumilast) Cream 0.05% for Atopic Dermatitis in Young Children Ages 2-5
Professional DevelopmentPharma

FDA Approves ZORYVE® (roflumilast) Cream 0.05% for Atopic Dermatitis in Young Children Ages 2-5

Arcutis Biotherapeutics, Inc. has announced the FDA approval of ZORYVE® (roflumilast) cream 0.05% for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years. This approval is supported by findings from the INTEGUM

Oct 12, 2025
Novartis Receives FDA Approval for Rhapsido® (Remibrutinib) as a Novel Treatment for Chronic Spontaneous Urticaria
Professional DevelopmentPharma

Novartis Receives FDA Approval for Rhapsido® (Remibrutinib) as a Novel Treatment for Chronic Spontaneous Urticaria

On September 30, 2025, Novartis announced the FDA approval of Rhapsido® (remibrutinib), marking it as the first oral Bruton’s tyrosine kinase inhibitor (BTKi) approved for the treatment of chronic spontaneous urticaria (CSU) in adults who r

Oct 11, 2025
FDA Approves TREMFYA® for Pediatric Psoriasis and Psoriatic Arthritis
Professional DevelopmentPharma

FDA Approves TREMFYA® for Pediatric Psoriasis and Psoriatic Arthritis

In a significant advancement for pediatric care, the U.S. Food and Drug Administration (FDA) has approved TREMFYA (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis (PsO) or active pso

Oct 09, 2025
Efficacy and Safety of Ruxolitinib Cream in Pediatric Atopic Dermatitis: TRuE-AD3 Study Findings
Professional DevelopmentPharma

Efficacy and Safety of Ruxolitinib Cream in Pediatric Atopic Dermatitis: TRuE-AD3 Study Findings

A phase 3 study (TRuE-AD3) evaluated the efficacy and safety of ruxolitinib cream in children aged 2-11 years with mild-to-moderate atopic dermatitis (AD). A total of 330 children were randomized to receive either vehicle, 0.75%, or 1.5% ru

Oct 03, 2025
FDA Approves Otezla® for Pediatric Psoriatic Arthritis in Patients 6 Years and Older
Clinical PracticePharma

FDA Approves Otezla® for Pediatric Psoriatic Arthritis in Patients 6 Years and Older

The FDA has granted approval for Otezla® (apremilast) to treat active psoriatic arthritis in pediatric patients aged 6 years and older who weigh at least 20 kg. This landmark approval is backed by robust evidence from controlled clinical tr

Aug 15, 2025
The efficacy of longer-term lebrikizumab treatment
Clinical PracticePharma

The efficacy of longer-term lebrikizumab treatment

This study evaluated the long-term efficacy of lebrikizumab in patients with moderate-to-severe atopic dermatitis who did not meet early treatment response criteria by week 16. Despite 38.1% of patients not reaching the defined response thr

Jun 17, 2025
Rilzabrutinib Shows Promise for Treating Tough Cases of Chronic Spontaneous Urticaria
Clinical PracticeProfessional Development

Rilzabrutinib Shows Promise for Treating Tough Cases of Chronic Spontaneous Urticaria

The phase 2 RILECSU clinical trial has brought encouraging news for patients suffering from chronic spontaneous urticaria (CSU) that doesn’t respond well to standard antihistamines. Rilzabrutinib, an investigational oral Bruton tyrosine kin

Jun 03, 2025
Topical steroid withdrawal diagnostic criteria defined by NIH researcher
Clinical PracticePharma

Topical steroid withdrawal diagnostic criteria defined by NIH researcher

Researchers at the National Institutes of Health (NIH) have uncovered new insights into dermatitis caused by topical steroid withdrawal (TSW), revealing that it is distinct from eczema and linked to high levels of a key chemical compound ca

May 05, 2025
Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-Year Long Term Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials Including Laboratory Parameters
Clinical PracticePharma

Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-Year Long Term Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials Including Laboratory Parameters

Deucravacitinib demonstrated a consistent safety profile over 5 years with more than 5,000 patient years of exposure, showing no increase in adverse events, serious adverse events, or the emergence of new safety signals. Rates of serious in

Apr 28, 2025
Lebrikizumab Improves Itch, Itch Interference on Sleep, and Skin Pain in Patients With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Clinical PracticeProfessional Development

Lebrikizumab Improves Itch, Itch Interference on Sleep, and Skin Pain in Patients With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

In the open-label ADapt trial, lebrikizumab demonstrated significant improvements in managing symptoms of AD like itch, sleep disruption due to itching, and skin pain in patients who had previously been treated with dupilumab. For those who

Apr 15, 2025