Showing 3001-3010 of 3415 results for "".
- Pulse Biosciences Scores FDA 510(k) Clearance of Expanded Energy Settings for CellFX Systemhttps://practicaldermatology.com/news/pulse-biosciences-scores-fda-510k-clearance-of-expanded-energy-settings-for-cellfx-system/2461289/The U.S. Food and Drug Administration (FDA) gave 510(k) clearance tp expanded energy settings for use with Pulse Biosciences, Inc.’s CellFX System treatments tips in dermatology. “Pulse Biosciences is dedicated to providing dermatologists a superior solution for the treatmen
- Zoryve from Arcutis Approved for Plaque Psoriasishttps://practicaldermatology.com/news/zoryve-from-arcutis-approved-for-plaque-psoriasis/2461282/FDA has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% from Arcutis Biotherapeutics for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. The first and only topical phosphodiesterase-4 (PDE4) inhib
- FDA Clears Use of Apyx Medical’s Renuvion Handpiece for Improvement in Appearance of Lax Skinhttps://practicaldermatology.com/news/fda-clears-use-of-apyx-medicals-renuvion-to-improve-appearance-of-lax-skin/2461273/The U.S. Food and Drug Administration received 510(k) clearance for the use of Apyx Medical’s Renuvion APR Handpiece for certain skin contraction procedures. Specifically, the Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aest
- Health Canada Clears Cutera’s AviClearhttps://practicaldermatology.com/news/health-canada-clears-cuteras-aviclear/2461268/Health Canada has cleared Cutera, Inc.’s AviClear for the treatment of mild, moderate, and severe acne. This Health Canada announcement comes on the heels of the U.S. Food and Drug Administration’s 510(k) clearance of AviClear, in March 2022. In addition
- To Keep Pace with Growth, Crown Builds Out Manufacturing Complexhttps://practicaldermatology.com/news/to-keep-pace-with-growth-crown-builds-out-manufacturing-complex/2461266/Crown Laboratories is adding 60,000 square feet to its manufacturing complex in Johnson City, TN. The facility is home to PanOxyl acne wash, Blue Lizard Australian Sunscreen, and Sarna anti-itch lotion. The additional 60,000 sq. ft. will bring the Lafe Cox Drive facility
- FDA Clears Soligenix's Synthetic Hypericin for Phase 2 Clinical Trial in Psoriasishttps://practicaldermatology.com/news/fda-clears-soligenixs-synthetic-hypericin-for-phase-2-clinical-trial-in-psoriasis/2461250/The U.S. Food and Drug Administration (FDA) has cleared Soligenix’s Investigational New Drug (IND) application for a Phase 2a clinical trial of topically-applied SGX302 (synthetic hypericin). Patient enrollment is slated to begin in the fourth quarter of 2022. "Duri
- Business News: Solta IPO Put on Icehttps://practicaldermatology.com/news/business-news-solta-ipo-put-on-ice/2461239/Bausch Health Companies Inc. is suspending its plans for the Solta IPO due to challenging market conditions and other factors. Bausch Health stated that the interests of the Company's stakeholders are best served in the near-term by focusing on driving Solta's revenue, profits a
- New Research Reveals Roughly 4 in 5 Acne Sufferers Have Missed Moments in Their Life Due to Acnehttps://practicaldermatology.com/news/new-research-reveals-roughly-4-in-5-acne-sufferers-have-missed-moments-in-their-life-due-to-acne/2461227/Ninety percent of moderate to severe acne sufferers said having acne-free skin would dramatically change the way they live their life, according to a new survey released today. The survey was conducted on behalf of Cutera, Inc., which offers AviClear, the first
- Apyx Medical Corporation Receives FDA 510(k) Clearance for Renuvion Handpiecehttps://practicaldermatology.com/news/apyx-medical-corporation-receives-fda-510k-clearance-for-renuvion-handpiece/2461216/The U.S. Food and Drug Administration has granted marketing clearance to Apyx Medical Corporation’s Renuvion Dermal Handpiece for specific dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to
- Verrica Receives Complete Response Letter from FDA for NDA for VP-102https://practicaldermatology.com/news/verrica-receives-complete-response-letter-from-fda-for-nda-for-vp-102/2461214/The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc.'s New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). According to the company, the only deficiency listed in the CRL was related to the deficiencies