Showing 1061-1070 of 1555 results for "".
- FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11https://practicaldermatology.com/news/fda-approves-arcutis-zoryve-roflumilast-cream-03-for-treatment-of-psoriasis-in-children-ages-6-to-11/2462045/The U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years. “T
- When Lightning Strikes: A Case Study of Staphylococcal Scalded Skin Syndrome in a 55-year-old Manhttps://practicaldermatology.com/news/when-lightning-strikes-a-case-study-of-staphylococcal-scalded-skin-syndrome-in-a-55-year-old-man/2462042/Five months after being struck by lightning, a 55-year-old male presented with a 2-day history of an erythematous rash. The patient noted his skin had been excessively dry since the lightning strike, and he recently added a new essential oil to his bath. His medical history includes liver failure
- AD Pipeline Update: FDA Rejects Lilly’s Lebrikizumab Due to Third-Party Manufacturing Issueshttps://practicaldermatology.com/news/ad-pipeline-update-fda-rejects-lillys-lebrikizumab-due-to-third-party-manufacturing-issues/2462037/The U.S. Food and Drug Administration (FDA) did not approve Eli Lilly's lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis due to findings during an inspection of a contract manufacturer. The letter cited findings
- Cabaletta Bio Receives FDA Clearance of IND Application for Treatment of Systemic Sclerosis with CABA-201https://practicaldermatology.com/news/cabaletta-bio-receives-fda-clearance-of-ind-application-for-treatment-of-systemic-sclerosis-with-caba-201/2462036/The U.S. Food and Drug Administration (FDA) is allowing Cabaletta Bio, Inc.’s third Investigational New Drug (IND) application for CABA-201 to proceed. for a Phase 1/2 study in patients with systemic sclerosis (SSc). CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell
- FDA Approves Merz Aesthetics’ Belotero Balance (+) for Infraorbital Hollowshttps://practicaldermatology.com/news/fda-approves-merz-aesthetics-belotero-balance-for-infraorbital-hollows/2462028/The U.S. Food and Drug Administration (FDA) approved Merz Aesthetics’ Belotero Balance (+) for improvement of the infraorbital hollow (IOH) in adults over the age of 21. This approval stems from positive pivotal study results demonstrating the efficacy and safety o
- Abeona Submits BLA for RDEB Treatmenthttps://practicaldermatology.com/news/abeona-submits-bla-for-rdeb-treatment/2462026/Abeona Therapeutics Inc. submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). <
- Arcutis Submits NDA for Roflumilast Cream 0.15% for AD Treatmenthttps://practicaldermatology.com/news/arcutis-submits-nda-for-roflumilast-cream-015-for-ad-treatment/2462001/Arcutis Biotherapeutics, Inc. submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older. Roflumilast cream is
- Study Sheds Light on Why Wounds Heal Poorly in People With Diabeteshttps://practicaldermatology.com/news/study-sheds-light-on-why-wounds-heal-poorly-in-people-with-diabetes/2461989/When exosomes are defective in diabetic patients, they can drive inflammation and impair healing of wounds, according to a new Nano Today study led by University of Pittsburgh and UPMC researchers
- Interim INTEGUMENT-OLE Results: Arcutis’ Roflumilast Cream 0.15% Performs Well in ADhttps://practicaldermatology.com/news/arcutis-roflumilast-cream-015-performs-well-in-ad/2461987/Roflumilast cream 0.15% showed durable and improved efficacy over time and a favorable safety profile in mild to moderate Atopic Dermatitis (AD), according to interim results from the INTEGUMENT-OLE long-term open-label study. Arcutis intends to submit a supplemental New Drug Applicatio
- Tarsus Rolls Out XDEMVY for Demodex Blepharitishttps://practicaldermatology.com/news/tarsus-rolls-out-xdemvy-for-demodex-blepharitis/2461985/Tarsus Pharmaceuticals, Inc. is rolling out XDEMVY, the First and Only US Food and Drug Administration-approved treatment for Demodex blepharitis. XDEMVY is now available at pharmacies nationwide for prescription. Bobak Azamian, MD, PhD, Chief Executive Officer, and Chairman, ran