Showing 3091-3100 of 3415 results for "".
- Bimini Health Tech’s Dermapose Access Office-Based Fat Harvesting System Scores FDA 510(k) clearancehttps://practicaldermatology.com/news/bimini-health-techs-dermapose-access-office-based-fat-harvesting-system-scores-fda-510k-clearance/2460368/Bimini Health Tech’s received US Food and Drug Administration (FDA) 510(k) clearance for its Dermapose Access, a novel fat harvesting system. Designed for office use, the launch of the Dermapose Access sy
- Label Expansion: Amgen's Otezla Adds Scalp Datahttps://practicaldermatology.com/news/label-expansion-amgens-otezla-adds-scalp-data/2460359/With FDA approval of a supplemental New Drug Application (sNDA), the label for Amgen's Otezla will now be updated to include scalp psoriasis data from the Phase 3 STYLE trial. The label expansion makes Otezla the only oral treatment option to have data specific to moderate
- Wontech Scores FDA Nod for Sandro Dual Laserhttps://practicaldermatology.com/news/wontech-scores-fda-nod-for-sandro-dual-laser/2460333/The U.S. Food and Drug Administration granted 510 (K) marketing clearance to Wontech’s Sandro Dual, a hybrid Nd:YAG & Alexandrite laser device. In the hybrid mode, by irradiating a short time difference between two wavelengths of 755nm and 1064nm, the laser accurately hits its
- FDA Greenlights Pfizer’s Eucrisa for Children As Young As Three Months With ADhttps://practicaldermatology.com/news/fda-greenlights-pfizers-eucrisa-for-children-as-young-as-three-months-with-ad/2460321/The U.S. Food and Drug Administration (FDA) gave its nod to Pfizer’s Eucrisa ointment, 2%, for children as young as age 3 months with mild-to-moderate atopic dermatitis (AD). Eucrisa was previously approved for use in adults and children 2 years of age and older. It is the first a
- Destiny Pharma and MedPharm Complete Initial Phase of Development Projecthttps://practicaldermatology.com/news/destiny-pharma-and-medpharm-complete-initial-phase-of-development-project/2460318/Destiny Pharma and MedPharm have completed the initial phase of their project to develop new topical formulations of Destiny’s novel XF‐platform drugs. Further to forming the collaboration with MedPharm last year, the project has identified a range of new, stable XF formulations w
- FDA Grants Breakthrough Status for Baricitinib in AAhttps://practicaldermatology.com/news/fda-grants-breakthrough-status-for-baricitinib-in-alopecia-1/2460308/The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Eli Lilly and Company and Incyte Corporation’s baricitinib for the treatment of alopecia areata (AA). Baricitinib is currently approved for the treatment of adults with moderately to severe
- AMA: New CPT Code to Report Novel Coronavirus Testhttps://practicaldermatology.com/news/ama-new-cpt-code-to-report-novel-coronavirus-test/2460307/The Current Procedural Terminology (CPT®)Editorial Panel has approved a new addition to the CPT code set to report testing for the virus that causes COVID-19. The American Medical Association (AMA) says the code will help streamline data-driven resource and allocation planning in t
- Cynosure's Four-Mode RF Microneedling Device Cleared for Marketinghttps://practicaldermatology.com/news/cynosures-four-mode-rf-microneedling-device-cleared-for-marketing/2460289/The U.S. Food and Drug Administration (FDA) cleared Cynosure’s Potenza, a four-mode radiofrequency (RF) microneedling device. The Potenza device comprises four modes (monopolar or bipolar, delivered at either 1 MHz
- Revance: FDA Accepts BLA for DaxibotulinumtoxinA, Sets November PDUFA Datehttps://practicaldermatology.com/news/revance-fda-accepts-bla-for-daxibotulinumtoxina-sets-november-pdufa-date/2460278/FDA has accepted the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar (frown) lines, Revance reports. The FDA set an action date of November 25, 2020 under the Prescription Drug User Fee Act (PDUFA) VI program.
- Survey: Many Men Don’t Wash Their Faces Every Dayhttps://practicaldermatology.com/news/survey-many-men-dont-wash-their-faces-every-day/2460266/One-third of men admit to not washing their faces daily, according to a poll of 1,000 men aged 18 and older conducted by AcuPoll for Tiege Hanley. The Men’s Skin Care Survey by Tiege Hanley found that younger men are more likely to drop the