Showing 141-150 of 381 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,&
- 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 decentraliz
- 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 recep
- 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
- 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
- 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 t
- 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
- Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agencyhttps://practicaldermatology.com/news/20140904-amgen_submits_marketing_authorization_application_for_talimogene_laherparepvec_to_the_european_medicines_agency/2459130/Amgen recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Talimogen
- Verisante Technology, Inc. Partners with the BC Cancer Foundation to Showcase Aura™ for Skin Cancer Detectionhttps://practicaldermatology.com/news/20140623-verisante_technology_inc_partners_with_the_bc_cancer_foundation_to_showcase_aura_for_skin_cancer_detection/2459196/Verisante Technology, Inc. is partnering with the BC Cancer Foundation to showcase Verisante Aura™, a device for the detection of skin cancer. Verisante has placed an Aura™ at the Foundation's Provincial Office in Vancouver for display and educa
- Promius Pharma, LLC Introduces Dr. Reddy's Authorized Generic Producthttps://practicaldermatology.com/news/20140225-promius_pharma_llc_introduces_dr_reddys__authorized_generic_product/2459331/Promius Pharma, LLC, launched its first Authorized Generic (AG) of Cloderm® Cream through its parent company Dr. Reddy's Laboratories on February 14. The AG is identical in formulation to Cloderm® Cream and will provide all the similar benefits, while increasing access and reducing pharmacy call