May 9th 2024
Patients who responded to imsidolimab in GEMINI-1 and who moved into GEMINI-2 maintained clear or almost clear skin.
VYNE expects to enroll the first patient with vitiligo in the phase 2b trial for VYN201 in the second quarter of 2024.
May 2nd 2024
The new research will compare eblasakimab to dupilumab and lebrikizumab.
April 30th 2024
A decision from the FDA is expected in the second half of 2024.
April 29th 2024
The FDA’s PDUFA date is expected in quarter 4 of 2024.
The JAK Inhibitor Pipeline Builds in Dermatology
Eight JAK inhibitors are approved by the FDA to treat autoimmune, inflammatory, and allergic conditions.
FDA Clears Brella SweatControl Patch for Reduced Primary Axillary Hyperhidrosis
Patients can achieve reduced excessive underarm sweating after one in-office treatment.
Pembrolizumab Plus Lenvatinib Phase 3 Melanoma Trial Discontinued
Merck and Eisai discontinued the trial based on recommendations of an independent data monitoring committee.
First Dosing of Patient in Phase 2 Study Evaluating VP-315 for BCC
Verrica Pharmaceuticals is developing a potentially first-in-class oncolytic peptide.
Q1 Accepted NDAs and sBLAs to Keep a Watchful Eye On
Three major NDAs and sBLAs were accepted by the FDA in Q1 of 2023, with PDUFA dates set in 2023 and 2024.
Investigational LEO Pharma IL-22 Receptor Improves EASI Scores in AD
Late-breaking positive phase 2a results were presented at AAD 2023.
Upadacitinib Advances to Phase 3 Clinical Trials in Systemic Lupus Erythematosus
The selective and reversible Janus kinase inhibitor is being studied in several immune-mediated inflammatory diseases.
FDA Approves Retifanlimab-Dlwr for the Treatment of Metastatic or Recurrent Locally Advanced MCC
Incyte’s MCC indication is approved under accelerated approval based on tumor response rate and duration of response.
New TMB-001 Sub-Analysis Data Published in Clinical and Experimental Dermatology
Timber Pharmaceuticals is on its way to developing the first FDA-approved treatment for congenital ichthyosis subtypes.
TMB-001 for Congenital Ichthyosis Subtypes Tested by Dermatologists
Yale School of Medicine is a testing site for a potential new congenital ichthyosis treatment.
FDA Accepts Novan’s NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum
Novan’s expected PDUFA date is January 5, 2024.
New Positive Results of Oral IL-23 Receptor Antagonist for Psoriasis
JNJ-2113 met primary endpoints in the FRONTIER 1 clinical trial.
Verrica Pharmaceuticals' Resubmitted NDA for VP-102 Accepted by FDA
VP-102 could be the first FDA-approved treatment for molluscum contagiosum.
FDA Accepts Bristol Myers Squibb’s sBLA for Nivolumab for Resected Stage IIB/C Melanoma
Nivolumab for completely resected stage IIB or IIC melanoma is also validated by the European Medicines Agency.
Bruce Feinberg, DO, Discusses 2023 Biosimilars Report From Cardinal Health
Biosimilars have been a trending topic in 2023 with 8 adalimumab biosimilars expected to hit the market this year.
Arcutis Submits NDA for Roflumilast Foam for the Treatment of Seborrheic Dermatitis
Adolescents and adults with seborrheic dermatitis may have a new topical treatment soon.
Abrocitinib Approved for Adolescents With Atopic Dermatitis
The expanded approval is based on data from a recent phase 3 clinical trial.
New Positive Phase 3 Data of Delgocitinib for Chronic Hand Eczema
Chronic hand eczema can have a significant negative impact on quality of life.
HS Treatment Response Rates Continue to Improve with Secukinumab at Week 52
Newly released safety and efficacy data on Novartis’ secukinumab for hidradenitis suppurativa is published in The Lancet.
First Adalimumab Biosimilar, Adalimumab-atto, Available in the US
Christopher Bunick, MD, PhD, and Raj Chovatiya, MD, PhD, discuss the benefits of adalimumab-atto and the future of additional biosimilars in 2023.
Spesolimab Shows Significant Prevention of GPP Flares up to 48 Weeks
Preventing generalized pustular psoriasis may be possible based on recent data.
Dermatology Drug Pipeline 2023
Breakthroughs and approvals we can expect in the coming year.
Novan Submits NDA for Berdazimer Gel for the Treatment of Molluscum Contagiosum
Potential FDA approval is expected in the first quarter of 2024.
SNDA Submitted for Roflumilast Cream for the Treatment of Plaque Psoriasis Down to 2 Years
Arcutis Biotherapeutics' indication expansion is based on data from MUSE studies.
Positive New Results of Tapinarof Cream Study for Pediatric Patients with AD
Dermavant announced positive results from its pediatric maximal usage study.
Eli Lilly Submits BLA for Lebrikizumab AD Treatment
BLA submission is based on phase 3 trial results evaluating the safety and efficacy of lebrikizumab.
FDA Accepts Phase 1 Clinical Trials of Exosome Therapy for AD
Brexogen Inc.’s exosome therapy is the first entry of a clinical trial of exosome treatment for atopic dermatitis.
Phase 2a Clinical Trial Enrollment for AD Passes Halfway Point
Alphyn Biologics’ study of AB-101a also evaluates patients who suffer from bacterial infections associated with atopic dermatitis.
New Study Data of Roflumilast Foam for Scalp and Body Psoriasis
Arcutis Biotherapeutics announced positive results from the ARRECTOR phase 3 trial.
FDA Approves Spesolimab-Sbzo Injection for GPP Flares
Boehringer Ingelheim’s first treatment option for adults will help manage burdensome flares.