Showing 5241-5250 of 10176 results for "".
- FDA Grants AbbVie's Upadacitinib Breakthrough Therapy Designation for Atopic Dermatitishttps://practicaldermatology.com/news/fda-grants-abbvies-upadacitinib-breakthrough-therapy-designation-for-atopic-dermatitis/2457932/The FDA granted Breakthrough Therapy Designation for AbbVie's investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This Breakthrough Therapy Designation is supporte
- FDA Approves BMS's Opdivo as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Diseasehttps://practicaldermatology.com/news/fda-approves-bmss-opdivo-as-adjuvant-therapy-in-patients-with-completely-resected-melanoma-with-lymph-node-involvement-or-metastatic-disease/2457941/The FDA has approved Bristol-Myers Squibb Company's Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The purpose of adjuvant therapy is to reduce t
- Allergan's CoolSculpting Treatment Now FDA Approved to Improve Appearance Of Lax Tissue in Double Chinhttps://practicaldermatology.com/news/allergans-coolsculpting-treatment-now-fda-approved-to-improve-appearance-of-lax-tissue-in-double-chin/2457956/The FDA has approved Allergan plc's CoolSculpting treatment for improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments. CoolSculpting for the double chin is already clinically proven to reduce fat up to 20 percent in the treated area after one tr
- FDA Grants Extended Clearance of the Describe Patch for Tattoo Removalhttps://practicaldermatology.com/news/fda-grants-extended-clearance-of-the-describe-patch-for-tattoo-removal/2457960/Merz North America’s DESCRIBE® PFD Patch is now cleared by the Food and Drug Administration (FDA) for all commonly used lasers for tattoo removal. The new FDA clearance also extends the shelf life of the Patch from two years
- FDA Accepts Ortho Dermatologic's NDA for Novel Plaque Psoriasis Treatment, IDP-118https://practicaldermatology.com/news/fda-accepts-ortho-dermatologics-nda-for-novel-plaque-psoriasis-treatment-idp-118/2457988/The US Food and Drug Administration has accepted Ortho Dermatologic's New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis. The PDUFA action date i
- FDA Adds Third Approved Indication for Botox Cosmetic: Forehead Lineshttps://practicaldermatology.com/news/fda-adds-third-approved-indication-for-botox-cosmetic-forehead-lines/2458032/Allergan plc's Botox Cosmetic received ts third FDA indication—the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial tre
- FDA Accepts NDAs for Review of Binimetinib And Encorafenib for Advanced BRAF-mutant Melanomahttps://practicaldermatology.com/news/fda-accepts-ndas-for-review-of-binimetinib-and-encorafenib-for-advanced-braf-mutant-melanoma/2458058/The FDA has accepted Array BioPharma's New Drug Applications (NDAs) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA se
- FDA Approves T.R.U.E. Test Ready-To-Use Patch Test for Pediatric Usehttps://practicaldermatology.com/news/fda-approves-true-test-ready-to-use-patch-test-for-pediatric-use/2458057/The FDA has approved SmartPractice's T.R.U.E. TEST (truetest.com) ready-to-use patch test panels for pediatric patients as young as 6 years of age. T.R.U.E. TEST is the only FDA-approved product for diagnosing allergic contact derm
- Galderma Names New Managers of Prescription Business and Aesthetic & Corrective Business Units; Dr. Kelly Huang to Obalonhttps://practicaldermatology.com/news/alisa-lask-to-oversee-galdermas-aesthetic-corrective-business-unit-dr-kelly-huang-to-obalon/2458064/Galdmera has named new managers of its Prescription Business and Aesthetic & Corrective Business units in the United States. Chris Chapman is Galderma’s new Vice President and General Manager of Prescription Business and Alisa Lask <
- FDA Expands Approval of Yervoy to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanomahttps://practicaldermatology.com/news/fda-expands-approval-of-yervoy-to-include-pediatric-patients-12-years-and-older-with-unresectable-or-metastatic-melanoma/2458113/The FDA has expanded the indication for Bristol-Myers Squibb's Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: