Showing 1161-1170 of 1539 results for "".
- FDA Accepts sNDA for Incyte's Opzelura for Vitiligohttps://practicaldermatology.com/news/fda-accepts-snda-for-incytes-opzelura-for-vitiligo/2461009/FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura™) a topical JAK inhibitor from Incyte, as a potential treatment for adolescents and adults with vitiligo. The sNDA is supported by data from the Phase 3 TRuE-V cl
- FDA Clears New Lifting Indications for Sofwavehttps://practicaldermatology.com/news/new-indications-for-sofwave/2460996/Sofwave is now U.S. Food and Drug Administration (FDA)-cleared for lifting the eyebrow and lifting lax submental tissue and neck tissue in people aged 22 or older. In addition, the Sofwave system featuring the Company's proprietary Superb TM (Synchronous Ultrasound Parallel Be
- FDA Fast Tracks Union Therapeutics' AD Candidatehttps://practicaldermatology.com/news/fda-fast-tracks-union-therapeutics-ad-candidate/2460978/The US Food and Drug Administration (FDA) has granted Fast Track designation to Union Therapeutics’ oral orismilast for the treatment of moderate to severe atopic dermatitis (AD). Orismilast is a next generation PDE4 inhibitor with broad anti-inflammatory properti
- 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