Showing 3061-3070 of 3448 results for "".
- Castle Creek Biosciences Awarded FDA Orphan Products Development Grant to Support Phase 3 Study of FCX-007 Investigational Gene Therapy for Recessive Dystrophic Epidermolysis Bullosahttps://practicaldermatology.com/news/castle-creek-biosciences-awarded-fda-orphan-products-development-grant-to-support-phase-3-study-of-fcx-007-investigational-gene-therapy-for-recessive-dystrophic-epidermolysis-bullosa/2460966/The U.S. Food and Drug Administration (FDA) Office of Orphan Products Development awarded Castle Creek Biosciences a $1.825 million research grant to support the Phase 3 development program of the investigational gene therapy FCX-007 for treatment of recessive dystrophic epide
- ASDSA Lauds FDA for Safety Communication on Needle-less Deviceshttps://practicaldermatology.com/news/asdsa-lauds-fda-for-safety-communication-on-needle-less-devices/2460952/The American Society for Dermatologic Surgery Association (ASDSA) applauds the U.S. Food and Drug Administration (FDA) for sending out a safety communication regarding needle-less devices, such as hyaluron pens (HA pens) for injection of dermal fillers. ASDSA had earlier
- Janssen Seeks FDA Nod for Stelara in Juvenile PsAhttps://practicaldermatology.com/news/janssen-seeks-fda-nod-for-stelara-in-juvenile-psa/2460949/Janssen is seeking expanded approval of Stelara (ustekinumab) for pediatric patients aged five and older with juvenile psoriatic arthritis (jPsA). The company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The filing is
- Safety Concerns Fuel Vaccine Hesitancy in PsO Patients on Biologics, But Data Fail to Show Increased Riskhttps://practicaldermatology.com/news/safety-concerns-fuel-vaccine-hesitancy-in-pso-patients-on-biologics-but-data-fail-to-show-increased-risk/2460947/Safety concerns and concerns about aggravation of their underlying condition are common drivers of COVID-19 vaccine hesitancy among patients with psoriatic disease, results of a new study show. Data come from an analysis of social media posts from patients in the US, UK, France, Germany, and
- Happy 25th Birthday Restylane!https://practicaldermatology.com/news/happy-25th-birthday-restylane/2460928/Galderma’s Restylane is celebrating 25 years on the market. Since launching in Europe in 1996, Restylane has celebrated many milestones across the globe. This includes the first approval for use by the U.S. Food and Drug Administration (FDA) in 2003 and in China by the
- FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreenshttps://practicaldermatology.com/news/fda-takes-steps-aimed-at-improving-quality-safety-and-efficacy-of-sunscreens/2460926/The U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. In the short term, these new authorities essentially preserve status
- Public Citizen to FDA: Pull Propecia from the Markethttps://practicaldermatology.com/news/public-citizen-to-fda-pull-propecia-from-the-market/2460908/Public Citizen today filed a lawsuit on behalf of the Post-Finasteride Syndrome Foundation (PFSF) against the U.S. Food and Drug Administration (FDA) fo
- FDA: Omeza's Collagen Matrix Cleared for Marketinghttps://practicaldermatology.com/news/fda-omezas-collagen-matrix-cleared-for-marketing/2460904/The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Omeza Collagen Matrix for chronic wound care. Omeza Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin pr
- FDA Accepts Dermavant's NDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasishttps://practicaldermatology.com/news/fda-accepts-dermavants-nda-for-tapinarof-cream-for-the-treatment-of-adults-with-plaque-psoriasis/2460886/The FDA has accepted Dermavant Sciences' New Drug Application (NDA) for tapinarof for the treatment of plaque psoriasis in adult patients. Tapinarof is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and
- ParaPRO’s Natroba for Scabies Now Availablehttps://practicaldermatology.com/news/parapros-natroba-for-scabies-now-available/2460877/ParaPRO’s Natroba (spinosad) Topical Suspension, 0.9% for scabies is now available. Natroba is the first new scabies drug to be approved by the U.S. Food and Drug Administration (FDA) in more than 30 years. Earlier this year, the company received FDA approval of its supp