Showing 1181-1190 of 1539 results for "".
- FDA Approves StrataGraft for the Treatment of Adults with Thermal Burnshttps://practicaldermatology.com/news/fda-approves-stratagraft-for-the-treatment-of-adults-with-thermal-burns/2460839/The U.S. Food and Drug Administration approved StrataGraft for the treatment of adult deep partial thickness burns. "Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. The goal of burn management is to help the patient ret
- FDA Approves Expanded Use of the RECELL System for Extensive Burns and Pediatric Patientshttps://practicaldermatology.com/news/fda-approves-expanded-use-of-the-recell-system-for-extensive-burns-and-pediatric-patients/2460831/The U.S. Food and Drug Administration (FDA) approved expanded use of the RECELL System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both pediatric and adult patients. Specifically, RECELL is now in
- FDA Grants Breakthrough Device Status to Alpha DaRT for SCChttps://practicaldermatology.com/news/fda-grants-breakthrough-device-status-to-alpha-dart-for-scc/2460829/The U.S. Food and Drug Administration (FDA) granted Alpha Tau Medical a Breakthrough Device Designation for Alpha DaRT for the treatment of squamous cell carcinoma (SCC) of the skin and oral cavity without curative standard of care. Alpha Tau submitted data to the FDA supporting this de
- Dermavant Submits NDA for Tapinarof for PsOhttps://practicaldermatology.com/news/dermavant-submits-nda-for-tapinarof-for-pso/2460820/Dermavant Sciences has submitted a New Drug Application (NDA) to the FDA for tapinarof for the treatment of mild, moderate, and severe plaque psoriasis in adult patients. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily,
- It's a RAP: Allergan Set to Acquire Solitonhttps://practicaldermatology.com/news/deal-time-allergan-set-to-acquire-soliton/2460801/Allergan Aesthetics is set to acquire Soliton and Resonic, its Rapid Acoustic Pulse device. Resonic recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite. The ac
- FDA Accepts Amgen's sNDA for Otezla in Mild-to-Moderate PsOhttps://practicaldermatology.com/news/fda-accepts-amgens-snda-for-otezla-in-mild-to-moderate-pso/2460796/FDA has accepted for review the supplemental New Drug Application (sNDA) for Amgen's Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a PDUFA action date of
- FDA Nod for Modifications to Soliton's Resonic Devicehttps://practicaldermatology.com/news/fda-nod-for-modifications-to-solitons-tattoo-removal-device/2460790/The U.S. Food and Drug Administration granted Soliton, Inc. 510(k) for modifications to its RESONIC device. The RESONIC device utilizes the RAP technology to deliver safe and effective tattoo removal and cellulite treatment and now includes an autoloading cartridge and an
- Natroba Now Approved for Scabies in Adults and Children as Young as Fourhttps://practicaldermatology.com/news/natroba-now-approved-for-scabies-in-adults-and-children-as-young-as-four/2460789/Natroba™ (spinosad) Topical Suspension, 0.9% is now approved as a topical treatment for scabies infestations in adult and pediatric patients four years of age and older. ParaPRO received approval of a supplemental New Dru
- UCB: Bimekizumab PDUFA Date Set for Octoberhttps://practicaldermatology.com/news/ucb-bimekizumab-pdufa-set-for-october/2460787/The FDA's Prescription Drug User Fee Act (PDUFA) date for UCB’s Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is October 15, 2021, UCB has indicated. In a
- Expert Opinion: Fleshing Out the Role of Biosimilars in Dermatologyhttps://practicaldermatology.com/news/expert-opinion-fleshing-out-the-role-of-biosimilars-in-dermatology/2460742/Two new studies of biosimilars of tumor necrosis factor blockers that are used to treat a number of dermatologic conditions suggest that they are equivalent to their originator drugs, but there may be more involved in making the decision about switching to a biosimilar than lower cost.