Blog
Zoryve Gets FDA Nod for Seborrheic Dermatitis in Patients as Young as Nine
Zoryve (roflumilast) topical foam, 0.3% from Arcutis Biotherapeutics has received FDA approval for the treatment of seborrheic dermatitis in individuals 9 years of age and older. Once-daily, steroid-free Zoryve is the first drug approved for seborrheic dermatitis with...
FDA Approves Expanded Indication for Tralokinumab for Pediatric AD
FDA has approved the expanded label for LEO Pharma’s Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those...
Comprehensive Meta-analysis Sheds Light on Safety of JAKs for Management of AD
By Joe Gorelick, MSN, FNP-C With 10 JAK inhibitors now approved by the FDA for use in the US across a range of indications, the significance of the boxed warning for JAK inhibitors to include the risk of major adverse events remains unclear. The lack of clarity with...
3 Novel Drugs Approved in Dermatology in 2023: FDA NDA Approvals Up vs. 2022
-- UPDATE: NDA Approvals for 2023 now stand at 54, with a fourth dermatologic indication approved! Filsuvez® (birch triterpenes) topical gel from Chiesi Global Rare Diseases has received FDA approval for the treatment of partial thickness wounds in patients 6 months...
Investigational Compounds Progress for Acne, AD
The Phase III clinical trial is now underway to evaluate fatty acid synthase (FASN) inhibitor ASC40 (Denifanstat) from Ascletis Pharma, Inc. for treatment of moderate to severe acne vulgaris. The randomized, double-blind, placebo-controlled, multicenter clinical trial...
FDA Accepts Supplemental NDA for Roflumilast 0.15% Cream for AD in Adults, Children as Young as Six
The FDA has accepted the supplemental new drug application (sNDA) from Arcutis Biotherapeutics, Inc. for roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) in adults and children down to age 6. The FDA assigned the application a Prescription Drug User...
Try This! Latest Dermalorian™ Podcast Features Dermatology Tips and Tricks
Day in and day out, dermatology care professionals face multiple decisions, record pages of medical data, and counsel patients on product selection and use. So what are the best ways to do these various tasks. Dermatology thought leaders share their recommendations in...
FDA Fast Tracks Oral Immunotherapy for Food Allergy
By Joe Gorelick, MSN, FNP-C The ability to treat food allergy with oral immunotherapy could be closer to clinical reality. The FDA has granted Fast Track Designation for ADP101, an investigational multi-food oral immunotherapy (mOIT) from Alladapt Immunotherapeutics,...
Researchers Identify New Potential Treatment for Melanoma, SCC
By Joe Gorelick, MSN, FNP-C An investigational anti-tumor compound may have efficacy against melanoma and squamous cell carcinoma (SCC), as well as lung cancer, researchers say. Plixorafenib (also called PLX8394) is currently in phase 2 clinical trials for melanoma...
Biologic Research Studies Lack Subject Images
In the published studies for biologic treatments for psoriasis, available images account for fewer than one subject per 1,000 participants, a new analysis concludes. More than three-quarters (77%) of studies contain no images at all. Researchers analyzed 152 different...