Showing 4341-4350 of 7112 results for "".
- FDA Grants AbbVie's Upadacitinib Breakthrough Therapy Designation for Atopic Dermatitishttps://practicaldermatology.com/news/fda-grants-abbvies-upadacitinib-breakthrough-therapy-designation-for-atopic-dermatitis/2457932/The FDA granted Breakthrough Therapy Designation for AbbVie's investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This Breakthrough Therapy Designation is supporte
- DermTech Receives Health Canada Approval to Market PLA and Non-invasive Biopsy Kithttps://practicaldermatology.com/news/dermtech-receives-health-canada-approval-to-market-pla-and-non-invasive-biopsy-kit/2457937/DermTech, Inc's licensee, DermTech Canada Inc., has received approval to market DermTech’s Pigmented Lesions Assay (PLA) and non-invasive biopsy kit for the detection of melanoma in Canada. DermTech Canada will market and sell the PLA, and samples will be processed at DermTech’s c
- FDA Approves BMS's Opdivo as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Diseasehttps://practicaldermatology.com/news/fda-approves-bmss-opdivo-as-adjuvant-therapy-in-patients-with-completely-resected-melanoma-with-lymph-node-involvement-or-metastatic-disease/2457941/The FDA has approved Bristol-Myers Squibb Company's Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The purpose of adjuvant therapy is to reduce t
- BridgeBio Pharma Appoints Drs. Sanuj Ravindran and Eric Michael David as CEOs-in-Residence to Lead Dermatology and Gene Therapy Programshttps://practicaldermatology.com/news/bridgebio-pharma-appoints-drs-sanuj-ravindran-and-eric-michael-david-as-ceos-in-residence-to-lead-dermatology-and-gene-therapy-programs/2457942/BridgeBio Pharma, a clinical-stage biopharmaceutical company, today announced that it has strengthened its executive leadership team with two key hires who will join the company as CEOs-in-residence. Sanuj Ravindran, MD, will serve as CEO of PellePharm, Inc. and wil
- BioPhotas, Inc. Launches the Newest Model of the Celluma Serieshttps://practicaldermatology.com/news/biophotas-inc-launches-the-newest-model-of-the-celluma-series/2457943/BioPhotas, Inc. launched its Celluma HOME, a fourth model in the Celluma Series of light therapy devices. The company says the Celluma HOME specifically addresses the challenges of Baby Boomers who struggle with wrinkles, aches and pain. FDA-cleared for over-the-counter purchase, available at an
- UCB: Bimekizumab Shows Joint and Skin Responses in Psoriatic Arthritishttps://practicaldermatology.com/news/ucb-bimekizumab-shows-joint-and-skin-responses-in-psoriatic-arthritis/2457945/UCB has announced that the Phase 2b BE ACTIVE study met the primary objective of establishing dose response for bimekizumab with statistical significance. The study also demonstrated robust efficacy in psor
- Biofrontera Files Investigational NDA for Phase 3 Trial of Ameluz for BCChttps://practicaldermatology.com/news/biofrontera-files-investigational-nda-for-phase-3-trial-of-ameluz-for-bcc/2457948/Biofrontera AG has filed an investigational new drug (IND) application with the FDA for its proposed Phase 3 study protocol to evaluate Ameluz® photodynamic therapy (PDT) for the treatment of superficial basal cell carcinoma. The IND filing is in accordance with the advice provided by F
- gel-e Receives US FDA Clearance to Expand its Bandage Product Line for Rx, OTC Usehttps://practicaldermatology.com/news/gel-e-receives-us-fda-clearance-to-expand-its-bandage-product-line-for-rx-otc-use/2457951/The U.S. Food and Drug Administration (FDA) has cleared gel-e Inc.’s adhesive bandage for prescription (Rx) and over-the-counter (OTC) use. This 510(k) clearance expands the Company's label to include the ma
- FDA Warns that Biotin May Interfere with Lab Test Resultshttps://practicaldermatology.com/news/fda-warns-that-biotin-may-interfere-with-lab-test-results/2457961/Biotin may significantly interfere with certain lab tests and cause "clinically significant incorrect lab test results," the US Food and Drug Administration warns. At least 1 death has been related to biotin interference with laboratory results, FDA officials wrote in a Saf
- New Analysis Provides Reassurance on Biosimilar Safetyhttps://practicaldermatology.com/news/new-analysis-provides-reassurance-on-biosimilar-safety/2457964/And they’re … safe. Biosimilars, which have been available in the European Union since 2006, show no substantial differences in the reporting of safety information than their originators, according to a new analysis in the