Showing 41-50 of 1548 results for "".
- Abeona Therapeutics Receives FDA Breakthrough Therapy Designation for EB-101 Autologous Cell Therapy in EBhttps://practicaldermatology.com/news/abeona-therapeutics-receives-fda-breakthrough-therapy-designation-for-eb-101-autologous-cell-therapy-in-eb/2458075/The U.S. Food and Drug Administration granted Breakthrough Therapy Designation status to the Abeona Therapeutics Inc.’s EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa. EB-101 is an autologous, ex-vivo gene-corrected cell therapy in which the COL7A1 gene is…
- Aclaris Submits Marketing Authorization Application in Europe for A-101 40% for Seborrheic Keratosishttps://practicaldermatology.com/news/aclaris-submits-marketing-authorization-application-in-europe-for-a-101-40-for-seborrheic-keratosis/2458100/Aclaris Therapeutics, Inc. has submitted a Marketing Authorization Application (MAA) with the Medicines Product Agency (MPA) in Sweden for its product candidate A-101 40% Topical Solution for the treatment of seborrheic keratosis. The MPA will act as the reference member state in this decentralized…
- LEO Pharma Receives EU Marketing Authorization for Kyntheum to Treat Plaque Psoriasishttps://practicaldermatology.com/news/leo-pharma-receives-eu-marketing-authorization-for-kyntheumfor-the-treatment-of-plaque-psoriasis/2458114/The European Commission has granted marketing authorisation for LEO Pharma's Kyntheum (brodalumab), a new biologic for the treatment of moderate-to-severe plaque psoriasis in adults within the European Union who are candidates for systemic therapy. Kyntheum selectively targets the IL-17 receptor su…
- Points Group and Dermatology Authority Launch the Derm Toolkit: A Revolutionary Service and Product Line for Dermatology Practiceshttps://practicaldermatology.com/news/points-group-and-dermatology-authority-launch-the-derm-toolkit-a-revolutionary-service-and-product-line-for-dermatology-practices/2458346/Points Group and Dermatology Authority are excited to announce the launch of the Derm Toolkit, an online portal that provides dermatology practices with a comprehensive set of tools and services to operate more effectively and grow their practices. Over the next four months, the Derm Toolkit will …
- Billionaire John Paul DeJoria Bets Big on Aubío for Cold Sores and Maybe Morehttps://practicaldermatology.com/news/billionaire-john-paul-digorio-bets-on-aubo-for-cold-sores-and-maybe-more/2458461/Billionaire John Paul DiJoria of Paul Mitchell Professional Hair Care Products and Patron Tequila fame is putting his money where his mouth is --- literally. DeJoria is now investing “heavily” in a new natural and sustainably produced over-the-counter (OTC) cold sore treatment called Aubío, and th…
- Cynosure Receives Health Canada Authorization to Market SculpSure®https://practicaldermatology.com/news/cynosure-receives-health-canada-authorization-to-market-sculpsure/2458503/Cynosure, Inc. received Health Canada Authorization to Market SculpSure® for non-invasive lipolysis of the abdomen and flanks. SculpSure is a fat-reduction laser intended for individuals with a body mass index (BMI) of 30 or less. The device can eliminate up to 24 percent of treated fat in a 25-m…
- Brickell Secures Rights to a Novel Class of RORγ Inhibitors for Psoriasis and Other Autoimmune Diseaseshttps://practicaldermatology.com/news/brickell-biotech-secures-rights-to-a-novel-class-of-ror-inhibitors-for-psoriasis-and-other-autoimmune-diseases/2458801/Brickell Biotech, Inc. has secured the exclusive world-wide rights to a series of novel retinoic acid–related orphan nuclear receptor gamma (RORy) inhibitors from Orca Pharmaceuticals (Orca) and New York University (NYU). This chemical series is based on intellectual property emerging from the labo…
- Ortek Therapeutics Files Patent Applications for New Microbiome to Reduce S. Aureus Proliferationhttps://practicaldermatology.com/news/ortek-therapeutics-files-patent-applications-for-new-microbiome-to-reduce-s-aureus-proliferation/2458808/Stony Brook University and Ortek Therapeutics, Inc. filed two patent applications in the United States and internationally for nutrient based compositions utilizing innovative microbiome technology. Developed at Stony Brook University, these compositions have been exclusively licensed to Ortek as p…
- Restylane Lyft Approved for Cheek Augmentation and Midface Contour Deficiencieshttps://practicaldermatology.com/news/restylane-lyft-approved-for-cheek-augmentation-and-midface-contour-deficiencies/2458917/The FDA approved Galderma's Restylane Lyft for cheek augmentation and the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane Lyft, formerly marketed as Perlane-L, is an injectable gel used to increase volume and smooth wrinkles in the face. With this ne…
- INC Research Signs Agreement to Perform FDA Due Diligence Audit of Regulatory Documents for Provectus Biopharmaceuticalshttps://practicaldermatology.com/news/20141014-inc_research_signs_agreement_to_perform_fda_due_diligence_audit_of_regulatory_documents_for_provectus_biopharmaceuticals/2459085/Provectus Biopharmaceuticals, Inc. has retained INC Research, a leading, global Phase I to IV contract research organization, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10. The audit will be conducted in two phases, both of which are expected to be completed…