November 20th 2024
The drug is the first FDA-approved treatment for moderate to severe HS that selectively inhibits both IL-17A and IL-17F.
November 14th 2024
Delgocitinib is indicated for adults with CHE who either do not respond to or cannot use topical corticosteroids.
November 12th 2024
Abeona's pz-cel has been granted a April 29, 2025, PDUFA date.
November 5th 2024
The target action review date has been pushed to March 12, 2025.
October 18th 2024
This represents the second approval of Zoryve outside the US.
Valisure's David Light Shares Insights Into Newly-Published Benzene and BPO Data
Light delves into the science behind the new peer-reviewed data assessing benzene presence and formation in benzoyl peroxide products.
BREAKING NEWS: Additional Study Confirms Reports of Benzene Presence, Formation in Benzoyl Peroxide Products at Room Temperature
New peer-reviewed research published in the Journal of Investigative Dermatology examined 111 products at room temperature.
LEO Pharma Presents Extensive Data at EADV
Key highlights of the presentations included data on delgocitinib for atopic hand eczema, and tralokinumab for head and neck atopic dermatitis.
AI-Driven Chemistry: The Design Process Behind Zasocitinib
Through collaboration with Nimbus Therapeutics and Schrodinger, zasocitinib’s AI-driven design maximizes its fit within the targeted enzyme.
FDA Accepts Roflumilast Foam sNDA for Scalp and Body Psoriasis
The FDA has set a PDUFA target action date of May 22, 2025.
FDA Approves UCB's Bimekizumab-bkzx for Psoriatic Arthritis
Bimzelx was also approved for non-radiographic axial spondyloarthritis and ankylosing spondylitis.
FDA Approves Lebrikizumab-lbkz for Moderate to Severe Atopic Dermatitis
Ebglyss is now approved for children and adults aged 12 years and older.
Drug Survival of Biosimilars, Originator TNF Inhibitors Similar
The rates of discontinuation due to inefficacy or adverse events for biosimilars and originators of etanercept and adalimumab were similar, according to an analysis of a prospective registry.
IBI363 Monotherapy Granted Fast Track Designation in US for Advanced Melanoma
The PD-1/IL-2α bispecific antibody fusion protein is intended for patients with unresectable locally advanced or metastatic melanoma.
Verrica Announces Positive Preliminary Topline Results From Part 2 of Phase 2 Study of VP-315 for BCC
The overall reduction of tumor size in all lesions treated in part 2 was approximately 86%.
FDA Approves Nemolizumab for the Treatment of Prurigo Nodularis
Galderma’s nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31.
FDA Approves Denileukin Diftitox for Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma
The approval is supported by positive phase 3 data for Lymphir in this indication.
Q&A: Alumis Inc. Initiates Phase 3 Clinical Program for ESK-001 in Plaque Psoriasis
Alumis' Martin Babler shared insights into the program for the TYK2 inhibitor and the company's next steps for its development.
Turn Therapeutics Reports Significant IGA and Cytokine Inhibition, Advances to Plans for In-Human Trial
This article represents the first time the news has been shared with the public. Turn's Founder and CEO, Bradley Burnam, shares details.
SLIDESHOW: Overview of July 2024 FDA Approvals
Take a deep dive into the 3 approvals for various dermatological conditions this month.
Roflumilast Cream 0.15% for Atopic Dermatitis Now Commercially Available
Approved down to the age of 6, the treatment is covered by 2 pharmacy benefit manager contracts to provide timely coverage.
Emerging Therapeutic for Non-Segmental Vitiligo: Merck’s MK-6194
Iltefat Hamzavi, MD, discusses the REGINA 007 phase 2 trial evaluating MK-6194 for the treatment of non-segmental vitiligo.
The FDA Approves Deuruxolitinib for Severe Alopecia in Adults
Along with the approval, Sun Pharma is introducing an access program to assist eligible patients in starting and adhering to the treatment.
Arcutis Submits sNDA for Roflumilast Foam to FDA for Scalp and Body Psoriasis
The submission to the FDA is supported by positive results from the ARRECTOR phase 3 trial.
FDA Approves Roflumilast Cream 0.15% For Atopic Dermatitis in Patients Aged 6 Years and Older
Patrick Burnett, MD, PhD, provides insights into the significance of Arcutis’ roflumilast cream 0.15% formulation and its impact on pediatric patients.
Arcutis Still Awaiting FDA Action for Roflumilast Cream 0.15% for AD
The planned PDUFA data was July 7, 2024.
VYNE's Iain Stuart, PhD, Talks Promise of VYN202 and BET Inhibition in Inflammatory and Psoriatic Disease
Iain Stuart, PhD, discusses VYN202's status and potential in psoriasis and immuno-inflammatory diseases.
FDA Approves Biosimilar Ustekinumab-ttwe for All Indications of Reference Medicine
Pyzchiva will be commercialized by Sandoz in the United States.
FDA Grants Investigational New Drug Clearance for Ensemble No.2 for Phase 1 Atopic Dermatitis Trial
Ensemble No.2, or ENS-002, is an investigational live biotherapeutic product first detected by Concerto Biosciences using its kChip technology.
Health Canada Authorizes Lebrikizumab for Moderate to Severe Atopic Dermatitis in Patients 12 Years and Older
Authorization for Eli Lilly's Ebglyss is based on positive results from the ADvocate 1, ADvocate 2, and ADhere studies.
FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis
Botanix Pharmaceuticals announced the approval of its sofpironium topical gel, 12.45% for adults and children ages 9 and older.
SFA-002 Shows Promise in Early Clinical Trial Psoriasis Cohorts
Stefan Weiss, MD, MBA, explains next steps for the oral treatment after the completion of phase 1b enrollment.
FDA Approves Tralokinumab Autoinjector for Adults With Moderate to Severe Atopic Dermatitis
LEO Pharma's Adbry, a single-dose autoinjector, is expected to become available to patients in the coming months.
Late-Breaker: Roflumilast Cream 0.15% Demonstrates Continued Improvement in AD Symptoms Through 56 Weeks
Roflumilast cream 0.15% is being evaluated for patients with mild to moderate atopic dermatitis down to 6 years.
SDPA Poster Reports Positive Phase 3 Results of Dupilumab for PN
Researchers found dupilumab improved itch and skin lesions regardless of atopic disease status in patients with PN.