Showing 2931-2940 of 3415 results for "".
- US FDA Nod for Generic Protopichttps://practicaldermatology.com/news/us-fda-nod-for-generic-protopic/2461939/The United States Food & Drug Administration (FDA) has approved Tacrolimus Ointment, 0.03%, Glenmark Pharmaceuticals’ generic version of Protopic Ointment, 0.03%. Glenmark's Tacrolimus Ointment, 0.03%, will be distributed in the U.S. by Glenmark Pharma
- Abeona Therapeutics Submits Briefing Package for Pre-BLA Meeting with FDA in August 2023https://practicaldermatology.com/news/abeona-therapeutics-submits-briefing-package-for-pre-bla-meeting-with-fda-in-august-2023/2461901/Abeona Therapeutics Inc. completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company’s pre-Biologics License Application (BLA) meeting in August 2023. The purpose of the meeting is to discuss the format, content, and accept
- US FDA Grants Breakthrough Device Designation to Marpe's Dermatology Screening Systemhttps://practicaldermatology.com/news/us-fda-grants-breakthrough-device-designation-to-marpes-dermatology-screening-system/2461900/The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Marpe Technologies full-body Dermatology Screening System. The Marpe System is designed to acquire and analyze total body images to support the identification of malignant and pre-malignant lesions,
- FDA Approves Verrica Pharmaceuticals’ YCANTH for Molluscum Contagiosumhttps://practicaldermatology.com/news/fda-approves-verrica-pharmaceuticals-ycanth-for-molluscum-contagiosum/2461882/The U.S. Food and Drug Administration (FDA) has given its nod to Verrica Pharmaceuticals Inc.’s YCANTH (cantharidin) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients aged two and older. "It's the only topical FDA-approved therapy
- Hoth Therapeutics Receives Protocol Approval for HT-001https://practicaldermatology.com/news/hoth-therapeutics-receives-protocol-approval-for-ht-001/2461873/Hoth Therapeutics, Inc. received approval from the Food & Drug Administration (FDA) for a protocol change in its Phase 2a clinical trial of HT-001. Participants will apply HT-001 Gel once per day for six weeks, during which the effect on treating acneiform rash and other skin
- FDA Clears Xstrahl’s Radiant Aura for NMSCshttps://practicaldermatology.com/news/fda-clears-radiant-aura-receives-us-food-and-drug-administration-fda-510k-clearance/2461871/The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Xstrahl’s Radiant Aura, an office-based radiation therapy for non-melanoma skin cancer (NMSC). “We developed Radiant Aura to deliver both electronic brachytherapy and superficial radiation therapy in
- Revian Red Hair Growth System Takes on CCCA in Second Studyhttps://practicaldermatology.com/news/revian-red-hair-growth-system-takes-on-ccca-in-second-study/2461864/Revian Red Hair Growth System is planning a second study to build on previous trial results as an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). The Revian Red Hair Growth System is a US Foof and Drug Administration- cleared, lightweight wirel
- Biosimilar Update: Humira Biosimilar Cyltezo Now Available in U.S.https://practicaldermatology.com/news/biosimilar-update-humira-biosimilar-cyltezo-now-available-in-us/2461831/Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), a U.S. Food and Drug Administration (FDA)-approved Interchangeable biosimilar to Humira (adalimumab), is now commercially available in the U.S. Cyltezo was initially approved as a biosimilar in 2017 for use in multi
- Dermatology Around the Globe: First JAK for AD Approved in Indiahttps://practicaldermatology.com/news/dermatology-around-the-globe-first-jak-for-ad-approved-in-india/2461828/Intas Pharmaceuticals Ltd launched TOFATAS –a Drugs Controller General of India (DCGI) -approved, Tofacitinib Ointment 2% w/w for the treatment of mild to moderate Atopic Dermatitis (AD) in patients 18 years and above experiencing flare-ups of the disease. "The
- FDA Clears Candela's Vbeam 595 nm Pulsed Dye Laser for the Treatment of Port Wine Stains and Hemangiomas in the Pediatric Populationhttps://practicaldermatology.com/news/fda-clears-vbeam-595-nm-pulsed-dye-laser-for-the-treatment-of-port-wine-stains-and-hemangiomas-in-the-pediatric-population/2461824/The U.S Food and Drug Administration has cleared candela’s Vbeam family of 595 nm wavelength pulsed dye lasers (PDL) to treat cutaneous capillary malformations, and infantile hemangiomas (IH)/congenital hemangiomas in the pediatric population (from birth – 21 years of age).