September 26th 2023
Abeona Therapeutics is seeking Priority Review and approval of the therapy for patients with recessive dystrophic epidermolysis bullosa.
September 12th 2023
The IL-17A inhibitor did not meet its phase 2b/3 clinical trial primary end point.
The submission follows the announcement of recent long-term data of the drug in patients ages 6 years and older.
August 1st 2023
Both companies are hoping to make a positive impact in the neoadjuvant setting of cutaneous squamous cell carcinoma.
July 27th 2023
V940-001 is the first phase 3 study of a planned comprehensive clinical development program initiated after the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
FDA Grants Priority Review to Spesolimab
The FDA grants Priority Review for spesolimab (BI655130; Boehringer Ingelheim) as a treatment for generalized pustular psoriasis.
Upadacitinib Receives FDA Approval for Active Psoriatic Arthritis
The FDA approves upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active psoriatic arthritis.
Ruxolitinib Cream Receives Priority Review
Ruxolitinib cream (Opzelura; Incyte) receives priority review of its supplemental New Drug Application as a treatment for patients with vitiligo.
New Roflumilast Vehicle Data Announced
Arcutis Biotherapeutics has announced data suggesting that the vehicle in the investigational roflumilast cream had similar moisturizing properties as a commercially marketed, dermatologist-recommended, ceramide-containing moisturizer in adults with mild eczema.
JAK Inhibitors: Drilling Down the Details
In this exclusive video interview, James Q Del Rosso, DO, gets into the details of JAK inhibitors, explaining how they work and cutting through the headlines around the treatments.
Hyperhidrosis and Emerging Treatments
We sit down in a video interview with David Pariser, MD, FACP, FAAD, the secretary and founding member of the International Hyperhidrosis Society to discuss hyperhidrosis identifiers and treatments in honor of Hyperhidrosis Awareness Month.
First Topical JAK Inhibitor Treats Whole-body AD
FDA approval of ruxolitinib (Opzelura, Incyte) adds the first new topical anti-inflammatory to the atopic dermatitis (AD) armamentarium in 50 years, but boxed warnings raise questions.
New Drugs Tackle Tough Challenges
Potential game-changers in the pipeline and newly FDA-approved treatments were highlighted in an overview of new drugs to watch at Maui Derm NP+PA Fall 2021 meeting.
Galderma, Sofregen Enter Agreement to Develop Silk-based Biostimulators
Galderma and Sofregen Medical announced they have entered into an agreement to co-develop a novel line of silk-based biostimulators that will enable immediate volume restoration and provide structure for new tissue generation.
Pipeline of Promise for Atopic Dermatitis
New therapies raise patient expectations for fast efficacy, lower costs, and fewer adverse effects.
Pipeline Updates in Melanoma
Possible melanoma treatments have had multiple newsworthy events since July 2021.
FDA Approves Ruxolitinib for Atopic Dermatitis
Incyte announced the FDA has approved its topical selective Janus kinase (JAK)1/JAK2 inhibitor ruxolitinib (Opzelura) for the treatment of mild to moderate atopic dermatitis.
Dermatology Times Chief Medical Editor Weighs in On Black Box Warning for JAK Inhibitors
In this exclusive video interview, Zoe Diana Draelos, MD, Dermatology Times chief medical editor, weighs in on the recent Black Box Warning issued by the FDA to certain JAK inhibitors.
FDA Approves Halobetasol Propionate Foam for Plaque Psoriasis in Adolescents
The FDA has approved halobetasol propionate foam, 0.05% (Lexette; Mayne Pharma), a potent topical corticosteroid, for the treatment of plaque psoriasis in adolescent patients.
Topical Remetinostat Effective, Tolerable in Basal Cell Carcinoma
The topical HDAC inhibitor remetinostat demonstrated favorable tolerability and clinically significant efficacy in reducing disease burden in patients with basal cell carcinoma, according to results from a phase 2 trial.
FDA Warns About Some JAK Inhibitors
Although JAK inhibitors have shown efficacy in treating challenging conditions, federal regulators continue their safety reviews.
FDA Requiring Black Box Warning for Certain JAK Inhibitors
The FDA is now requiring black box warning for certain JAK inhibitors used to treat arthritis. This news comes amid delay in FDA approval for multiple JAK inhibitors for the treatment of inflammatory skin conditions.
Abrocitinib and Topical Therapy Safe, Effective for Atopic Dermatitis in Teens
A phase 3 trial studied the effectiveness of oral abrocitinib along with topical therapy for moderate-to-severe atopic dermatitis in teens.
Dupilumab Improves Chronic Spontaneous Urticaria Symptoms
A recent statement by Regeneron noted that chronic spontaneous urticaria is the fifth disease associated with positive Phase 3 results involving the monoclonal antibody.
FDA Sets PDUFA Date for Pembrolizumab
The FDA has granted priority review to Merck’s application for pembrolizumab, a treatment for melanoma.
Bimekizumab Demonstrates Positive Long-term in Phase 3 Psoriasis Trial
UCB announced that more than 90% of patients treated with bimekizumab have maintained IGA 1/0 results in their long-term BE BRIGHT trial.
FDA Accepts New Drug Application for Tapinarof in Plaque Psoriasis
The FDA has accepted the New Drug Application (NDA) for tapinarof as a treatment for plaque psoriasis in adults and set the PDUFA target action date to Q2 2022.
FDA Delays Impacting Inflammatory Skin Disease Community
Mark Lebwohl, MD, explains the recent delay in approval of JAK inhibitors by the FDA, how it is affecting the inflammatory skin disease community, and if physicians should be concerned.
FDA Grants Priority Review to Adjuvant Pembrolizumab for Stage II High-Risk Melanoma
The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.
Upadacitinib Superior to Dupilumab in Atopic Dermatitis
The results from the Heads Up study were published in JAMA Dermatology, which demonstrated upadacitinib was superior to dupilumab in treating atopic dermatitis.
Ritlecitinib Delivers Topline Results in Alopecia Areata Study
Ritlecitinib, an investigational covalent kinase inhibitor, achieved its primary endpoint and demonstrated statistically significant efficacy compared to placebo in treating alopecia areata.
Twyneo Approval Shakes up Acne Treatment World
Joshua Zeichner, MD, associate professor of dermatology and director of cosmetic & clinical research in dermatology, Mount Sinai Hospital, New York, discusses the impact of the recent FDA approval of Twyneo (Sol-Gel) for the treatment of acne.
FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma
Immunotherapy agent nemvaleukin alfa was granted an FDA fast track designation for the treatment of patient’s mucosal melanoma for previously undergone treatment with an anti-PD-L1 therapy.
MediWound Announced Positive Phase 3 Trial Results
MediWound Ltd, announced the results for its CIDS trial studying NexoBrid as a treatment for children with severe thermal burns.
Dalbavancin Receives FDA Approval for ABSSSI in Children
Dalbavancin has received FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients.
2 Clarke Drive Cranbury, NJ 08512