Showing 1391-1400 of 1535 results for "".
- ChloraDerm Launches Pediatric Offeringhttps://practicaldermatology.com/news/chloraderm-launches-pediatric-offering/2458683/entrotech life sciences (ELS) announced the availability of FDA-Cleared ChloraDerm in a new 1.75"x 1.75" configuration, ideal for pediatric patient use. ChloraDerm is the only transparent film dressing containing the Chlorhexidine Advantage, a safe, colophony-and acid-free, edge-t
- Cipher's Sitavig Accepted for Review by Health Canadahttps://practicaldermatology.com/news/ciphers-sitavig-accepted-for-review-by-health-canada/2458701/Cipher Pharmaceuticals Inc.’s New Drug Submission for Sitavig has been accepted for review by Health Canada. Sitavig (acyclovir mucoadhesive buccal tablets) is proposed for the treatment of recurrent herpes labialis in adults. In the United States, Sitavig® is approve
- FDA Accepts Allergan's sNDA for TEFLARO Use in Childrenhttps://practicaldermatology.com/news/fda-accepts-allergans-snda-for-teflaro-use-in-children/2458700/The U.S. Food and Drug Administration (FDA) has accepted Allergan’s supplemental New Drug Application (sNDA) for IV antibacterial TEFLARO® (ceftaroline fosamil). If approved, this filing will expand the label of TEFLARO beyond adults to include children two months of age a
- Biosimilar News: Sandoz Acquires Biosimilar Infliximab In EEA, FDA Panel Urges Approval of Biosimilar Infliximab in UShttps://practicaldermatology.com/news/biosimilar-new-sandoz-acquires-biosimilar-infliximab-in-eea-fda-panel-urges-approval-of-biosimilar-infliximab-in-us/2458705/Two days after a US Food and Drug Administration (FDA) advisory panel voted to recommend approval of the biosimilar form of Remicade (Infliximab), Novartis’ Sandoz unit has acquired rights to develop and commercialize a biosimilar to Remicade® (i
- ZELTIQ® Taps Todd Zavodnick as New President, Internationalhttps://practicaldermatology.com/news/zeltiq-taps-todd-zavodnick-as-new-president-international/2458708/Todd Zavodnick is the new President, International of ZELTIQ®. Mr. Zavodnick will be responsible for driving the company’s international growth and expansion. He rec
- Vyome Biosciences: FDA Has Accepted IND for Investigational Acne Therapyhttps://practicaldermatology.com/news/vyome-biosciences-fda-has-accepted-ind-for-investigational-acne-therapy/2458728/The FDA has accepted from Vyome Biosciences an Investigational New Drug (IND) Application for the initiation of clinical studies for its lead program VB 1953, a topical therapeutic candidate for the treatment of moderate-to-severe acne. Vyome plans to start the Phase I clinical trials very soon.<
- FDA Approves Updated Label for New Dosing Regimen for Allergan's Dalvancehttps://practicaldermatology.com/news/fda-approves-updated-label-for-new-dosing-regimen-for-allergans-dalvance/2458741/The FDA has approved Allergan plc’s supplemental new drug application (sNDA) to update the label for Dalvance® (dalbavancin) for injection. The expanded label will include a single dose administered as a 30-minute intravenous (IV) infusion of Dalvance for the treatment o
- AADA Provides Input on Skin Cancer Screening Recommendationhttps://practicaldermatology.com/news/aada-provides-input-on-skin-cancer-screening-recommendation/2458761/Recognizing the importance of early detection, the American Academy of Dermatology Association (AADA) has responded to the U.S. Preventive Services Task Force Draft Recommendation Statem
- Anacor Submits NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitishttps://practicaldermatology.com/news/anacor-submits-nda-for-crisaborole-topical-ointment-2-for-the-treatment-of-mild-to-moderate-atopic-dermatitis/2458765/Anacor Pharmaceuticals, Inc. has submitted a New Drug Application (NDA) to the US FDA seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic d
- Rock Creek Pharmaceuticals Adds KOLs to Enhance Dermatological Disease Programhttps://practicaldermatology.com/news/rock-creek-pharmaceuticals-adds-kols-to-enhance-dermatological-disease-program/2458794/Rock Creek Pharmaceuticals, Inc., a clinical stage drug development company focused on the application of its lead compound being developed to treat chronic inflammatory conditions, has retained two Key Opinion Leaders (KOLs), each having renowned international expertise in dermatological d