Showing 2031-2040 of 5839 results for "".
- FDA Gives Nod to Marketing DermaSensor for Skin Lesion Evaluationhttps://practicaldermatology.com/news/fda-gives-nod-to-dermasensor-for-skin-lesion-evaluation/2462213/The U.S Food and Drug Administration (FDA) announced that it has granted authorization for marketing for the DermaSensor (DermaSensor Inc.) prescription device, indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients ag
- Researchers Identify Factors Limiting New Treatment Decisions for HShttps://practicaldermatology.com/news/factors-affecting-treatment-selection-among-patients-with-hidradenitis-suppurativa/2462211/Researchers seeking to address the gap between evidence-based guidelines and clinical practice in the treatment of hidradenitis suppurativa (HS) have identified several factors influencing patient decision-making. The open-ended, two-center study, conducted through open-ended interviews
- FDA Deems Vaporized Hydrogen Peroxide an Established Method of Sterilizationhttps://practicaldermatology.com/news/fda-deems-vaporized-hydrogen-peroxide-an-established-method-of-sterilization/2462205/The U.S. Food and Drug Administration (FDA) announced that it now considers vaporized hydrogen peroxide (VHP) as an established method of sterilization for medical devices. In what the agency called a recognition of its long-time effectiveness, it revised the final guidance on the
- Novartis Set to Acquire Calypso Biotech, Focused on IL-15 Targeted Therapieshttps://practicaldermatology.com/news/novartis-set-to-acquire-calypso-biotech-focused-on-il-15-targeted-therapies/2462204/European-based biotech manufacturer Calypso has entered into an agreement to be acquired by Novartis, according to a press release. "We are excited for this transaction with Novartis," Calypso CEO and Founder Alain Vicari said in a news release. "As part of the
- Birch Triterpenes Topical Gel Gets FDA Approval for Treatment of Epidermolysis Bullosahttps://practicaldermatology.com/news/birch-triterpenes-topical-gel-gets-fda-approval-for-treatment-of-epidermolysis-bullosa/2462190/Chiesi Global Rare Diseases announced today that the FDA had approved FILSUVEZ® (birch triterpenes) topical gel for the treatment of junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB) in patients 6 months or older. According
- Can-Fite Receives Positive Response from FDA for Psoriasis Pediatric Planhttps://practicaldermatology.com/news/can-fite-receives-positive-response-from-fda-for-psoriasis-pediatric-plan/2462187/The U.S. Food and Drug Administration (FDA) gave a positive response to a study plan for piclidenoson in children suffering from psoriasis. The plan allows for children to enroll in the phase 3 pivotal clinical study aiming at registering the drug with both the FDA as well as the Europe
- FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Patients 9 Years and Olderhttps://practicaldermatology.com/news/fda-approves-arcutis-zoryve-roflumilast-topical-foam-03-for-the-treatment-of-seborrheic-dermatitis-in-patients-9-years-and-older/2462186/Arcutis Biotherapeutics, Inc. announced the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in those 9 years of age and older. ZORYVE foam provides rapid disease clearance and
- FDA Approves Adbry (tralokinumab-ldrm) for Treatment of Moderate-to-Severe AD in Pediatric Patients Aged 12-17 Yearshttps://practicaldermatology.com/news/fda-approval-of-tralokinumab-ldrm-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-pediatric-patients-aged-12-17-years/2462185/The US Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies
- Intradermal AIV001 Found Safe in Early BCC Studyhttps://practicaldermatology.com/news/intradermal-aiv001-found-safe-in-early-bcc-study/2462178/AiViva Biopharma Inc. completed its first trial administering AIV001 (axitinib) to patients diagnosed with basal cell carcinoma (BCC) tumors. AIV001 is intradermally administered and designed for local, prolonged treatment effect for dermatological conditions. The phase
- Kymera Update: First Patient Dosed in Phase 2 AD Clinical Trial of KT-474, a First-in-Class Investigational IRAK4 Degraderhttps://practicaldermatology.com/news/kymera-update-first-patient-dosed-in-phase-2-ad-clinical-trial-of-kt-474-a-first-in-class-investigational-irak4-degrader/2462177/The first patient has been dosed in the Phase 2 clinical trial (ADVANTA) evaluating KT-474 in AD, generating a $15 million milestone payment under its collaboration with Sanofi. KT-474 is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflamma