Showing 741-750 of 1478 results for "".
- FDA Nod for Cyltezo Autoinjector Penhttps://practicaldermatology.com/news/fda-nod-for-cyltezo-autoinjector-pen/2461738/The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). Cyltezo is an FDA-approved interchangeable biosimilar to Humira (adalimumab). Initially approved as a pre
- First Patient Dosed in TrialSpark's Phase 2 Trial of ASN008-201 in ADhttps://practicaldermatology.com/news/first-patient-dosed-in-trailsparks-phase-2-trial-of-asn008-201-in-ad/2461736/The first patient has been dosed in TrialSpark’s Phase 2 clinical trial for ASN008-201, a topical sodium channel blocker in development for pruritus associated with atopic dermatitis (AD). This clinical trial is a randomized, double-blind, vehicle-controlled, Phase 2 tr
- Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging Systemhttps://practicaldermatology.com/news/orlucent-receives-fda-breakthrough-device-designation-for-handheld-mole-imaging-system/2461733/The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Orlucent’s Skin Fluorescence Imaging System. The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively identify and clinically assess the pres
- FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with DEBhttps://practicaldermatology.com/news/fda-approves-first-topical-gene-therapy-for-treatment-of-wounds-in-patients-with-deb/2461732/The U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) g
- More Phase 3 Data: Dermavant’s VTAMA Hits Primary and Secondary Endpoints for Kids and Adults with ADhttps://practicaldermatology.com/news/phase-3-data-dermavants-vtama-hits-primary-and-secondary-endpoints-for-kids-and-adults-with-ad/2461720/Dermavant Sciences’ VTAMA performed well in in adults and kids with atopic dermatitis, according to topline results from ADORING 1, the company’s second atopic dermatitis (AD) Phase 3 trial. VTAMA is a novel, aryl hydrocarbon receptor agonist, in development a
- Oral IL-23 Receptor Antagonist Makes Waves in Tokyohttps://practicaldermatology.com/news/oral-il-23-receptor-antagonist-makes-waves-in-tokyo/2461716/Protagonist Therapeutics and Janssen Biotech, Inc.'s oral IL-23 receptor antagonist, JNJ-2113, performed well in Phase 1 and Pre-clinical Studies. JNJ-2113 is a macrocyclic peptide that binds to the IL-23 receptor with single digit picomolar affinity and demonstr
- Rare Skin Disease Update: Abeona's EB-101 Performs Well in a Phase 3 study of RDEBhttps://practicaldermatology.com/news/rare-skin-disease-update-abeonas-eb-101-performs-well-in-a-phase-3-study-of-rdeb/2461715/Abeona Therapeutics Inc.’s investigational EB-101 performed well in a Phase 3 study of recessive dystrophic epidermolysis bullosa (RDEB). Both co-primary endpoints were met, with the majority (81.4%) of randomized EB-101–treated wounds demonstrating ≥50% healing compared
- Cutera Update: Agreements Made With Pura Vida and RTW; New Board Members Appointedhttps://practicaldermatology.com/news/cutera-update-agreements-made-with-pura-vida-and-rtw-new-board-members-appointed/2461712/Cutera announced that it has entered into cooperation agreements with two of its largest stockholders, Pura Vida Investments LLC and RTW Investments LP, which collectively own more than 15% of the company’s outstanding shares. Pursuant to the agreements, Cutera will appo
- Resilia Pharmaceuticals Announces Return to Market of Neosalus Cream and Neosalus Lotionhttps://practicaldermatology.com/news/resilia-pharmaceuticals-announces-return-to-market-of-neosalus-cream-and-neosalus-lotion/2461697/Resilia Pharmaceuticals, Inc.’s Neosalus Cream and Neosalus Lotion are back. These products had not been available due to supply chain disruptions that occurred as a result of the COVID-19 public health crisis. Both Neosalus Lotion and Neosalus Cream use paten
- Cytrellis Taps New CTOhttps://practicaldermatology.com/news/cytrellis-taps-new-cto/2461695/Dr. Shiv Sabesan is Cytrellis Biosystems’ Chief Technology Officer. In his new role, Dr. Sabesan will lead the company's strategy as it continues to advance its proprietary ellacor Micro-Coring technology and expand indications. The technology was