Showing 1411-1420 of 1555 results for "".
- 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
- Immune Pharmaceuticals: FDA Accepts IND Application for Bertilimumab for Bullous Pemphigoidhttps://practicaldermatology.com/news/immune-pharmaceuticals-fda-accepts-ind-application-for-bertilimumab-for-bullous-pemphigoid/2458813/Immune Pharmaceuticals, Inc. has indicated that the FDA has accepted the Company's Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). This FDA acceptance enables the Company to expand recruitme
- Phase 3 Data Show Promius Pharma's DFD-01 Met Primary Endpoints for the Treatment of Moderate Psoriasishttps://practicaldermatology.com/news/phase-3-data-show-promius-pharmas-dfd-01-met-primary-endpoints-for-the-treatment-of-moderate-psoriasis/2458833/Findings from two Phase III studies for Promius Pharma’s investigational psoriasis drug DFD-01 show that the agent achieved the primary endpoint at day 15. The primary endpoint was the proportion of patients achieving treatment success at day 15 for both studies. In addition, both stud
- FDA Accepts sNDA for Dalvancehttps://practicaldermatology.com/news/fda-accepts-snda-for-dalvance/2458849/The FDA accepted Allergan's supplemental New Drug Application (sNDA) to expand the label to include single-dose administration of DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by design
- Revance Therapeutics Initiates Phase 3 Clinical Trial of Botulinum Toxin Type A Topical Gel for Crow's Feethttps://practicaldermatology.com/news/revance-therapeutics-initiates-phase-3-clinical-trial-of-botulinum-toxin-type-a-topical-gel-for-crows-feet/2458857/Revance Therapeutics, Inc. has commenced dosing patients in the Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical drug product candidate for the treatment of lateral canthal lines, or crow’s feet. The Phase 3 trial will evaluate the safety and ef
- Novan's SB204 Demonstrates Positive Phase 2b Clinical Trial Results for the Treatment of Acne Vulgarishttps://practicaldermatology.com/news/novans-sb204-demonstrates-positive-phase-2b-clinical-trial-results-for-the-treatment-of-acne-vulgaris/2458863/Novan Therapeutics topical nitric oxide drug candidate SB204 for the treatment of acne vulgaris, demonstrated statistically significant reductions in the percent change of non-inflammatory (white heads and black heads) and
- FDA Approves Humira for Moderate to Severe Hidradenitis Suppurativahttps://practicaldermatology.com/news/fda-approves-humira-for-moderate-to-severe-hidradenitis-suppurativa/2458873/The FDA approved AbbVie’s HUMIRA® (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). HUMIRA is now the first and only FDA-approved therapy for adults with HS. Earlier this year, the FDA granted HUMIRA orphan drug designation for t