Showing 1901-1910 of 2743 results for "".
- Coming Soon? The first FDA-approved Topical Prescription Product for Molluscumhttps://practicaldermatology.com/news/coming-soon-the-first-fda-approved-topical-prescription-product-for-molluscum/2461485/Ligand Pharmaceuticals Inc.’s partner Novan submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for berdazimer gel, 10.3% (SB206) for the topical treatment of molluscum contagiosum. Assuming the filing is accepted b
- Leo Pharma's Adtralza Gets Nod or Adults with AD in Japanhttps://practicaldermatology.com/news/leo-pharmas-adtralza-gets-nod-or-adults-with-ad-in-japan/2461476/The Japan Ministry of Health, Labor and Welfare has granted approval for the manufacturing and marketing of LEO Pharma’s Adtralza (tralokinumab) subcutaneous injection for adults with atopic dermatitis, which has inadequately responded to conventional therapies. “Today&
- Rocatinlimab Shows Promise in ADhttps://practicaldermatology.com/news/rocatinlimab-shows-promise-in-ad/2461465/Rocatinlimab—a novel, patient-tailored monoclonal antibody therapy—showed promising results in atopic dermatitis patients both while taking the drug and up to 20 weeks after the therapy was stopped, Mount Sinai researchers reported in
- DermTech, Sonora Quest Laboratories Join Forces Expand Access to Melanoma Detection Test in Arizonahttps://practicaldermatology.com/news/dermtech-sonora-quest-laboratories-join-forces-expand-access-to-melanoma-detection-test-in-arizona/2461434/Sonora Quest is the exclusive laboratory offering the DermTech Melanoma Test for all of Arizona. The DermTech Melanoma Test uses a non-invasive Smart Sticker to lift skin cells from the surface of a patient’s skin to be tested for select genomic markers associated with melanoma. I
- EMA Accepts Filing of MAA for Almirall's Lebrikizumab in ADhttps://practicaldermatology.com/news/ema-accepts-filing-of-maa-for-almiralls-lebrikizumab-in-ad/2461408/The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for Almirall’s lebrikizumab for the treatment of moderate to severe atopic dermatitis. Lebrikizumab is a novel, investigational, monoclonal antibod
- European Commission Approves LEO Pharma’s Adtralza (tralokinumab) for the Treatment of Moderate-to-Severe AD in Adolescentshttps://practicaldermatology.com/news/european-commission-approves-leo-pharmas-adtralza-tralokinumab-for-the-treatment-of-moderate-to-severe-ad-in-adolescents/2461394/The European Commission (EC)e xtended the marketing authorization for LEO Pharma’s Adtralz (tralokinumab) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. “Safety is a priority when s
- U.S FDA Clears EndyMed’s Hair Removal Devicehttps://practicaldermatology.com/news/fda-clears-endymeds-hair-removal-device/2461393/The US Food and Drug Administration has cleared Endymed Ltd’s Pure Laser hair removal device for the marketing and sales. The Pure Laser was developed in the Company's labs by its subsidiary Endymed Medical Ltd. The Company intends to commence marketing in the US th
- Hugel Resubmits Botulax BLA to FDAhttps://practicaldermatology.com/news/hugel-resubmits-botulax-bla-to-fda-1/2461380/Hugel resubmitted the BLA for its botulinum toxin called Botulax for smoothing glabellar lines to the U.S. FDA. Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) to advance into the U.S. market i
- FDA Clears CellFX System for the Treatment of SHhttps://practicaldermatology.com/news/fda-clears-cellfx-system-for-the-treatment-of-sh/2461358/The U.S. Food and Drug Administration (FDA) granted Pulse Bioscience’s CellFX System (FDA) 510(k)marketing clearance for the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-II. This specific indication clearance enhances the CellFX
- New Partnership for Revision Skincare, RVL Pharmaceuticalshttps://practicaldermatology.com/news/new-partnership-for-revision-skincare-rvl-pharmaceuticals/2461320/With a goal to collaborate on a variety of marketing efforts within the medical aesthetics industry, Revision Skincare® and RVL Pharmaceuticals, Inc. the owner of UPNEEQ®, are partnering to address what they see as significant unmet consumer needs. Revisions