Showing 2911-2920 of 3415 results for "".
- Experts React to FDA Approval of Cabtreo Topical Gel for Acne Vulgarishttps://practicaldermatology.com/news/fda-approves-cabtreo-topical-gel-for-acne-vulgaris/2462087/The U.S. Food and Drug Administration (FDA) has approved CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel for the topical treatment of acne vulgaris in patients aged 12 and older. Bausch Health and Ortho Dermatologics' CABTREO is the first and
- FDA Approves UCB’s BIMZELX for the Treatment of Adults with Moderate to Severe Plaque Psoriasishttps://practicaldermatology.com/news/fda-approves-ucbs-bimzelx-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis/2462079/The U.S. Food and Drug Administration (FDA) has approved BIMZELX (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is the first and only approved psoriasis treatment desi
- IDEAYA Biosciences Announces Phase 2 Expansion of Darovasertib and Crizotinib Combination in GNAQ/11 Metastatic Cutaneous Melanomahttps://practicaldermatology.com/news/ideaya-biosciences-announces-phase-2-expansion-of-darovasertib-and-crizotinib-combination-in-gnaq11-metastatic-cutaneous-melanoma/2462076/IDEAYA Biosciences, Inc. is initiating of a Phase 2 expansion of the darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma. There are currently no U.S Food and Drug Administration-approved therapies for this genetically-defined patient population. Darova
- FDA Approves BMS’ Opdivo (Nivolumab) for Adjuvant Treatment of Eligible Patients with Completely Resected Stage IIB or IIC Melanomahttps://practicaldermatology.com/news/fda-approves-bms-opdivo-nivolumab-for-adjuvant-treatment-of-eligible-patients-with-completely-resected-stage-iib-or-iic-melanoma/2462074/The U.S. Food and Drug Administration (FDA) has given its nod to Opdivo (nivolumab) for the adjuvant treatment of eligible adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma. This approval was based on the Phase 3
- FDA Approves Novartis Cosentyx as First IV Formulation IL-17A Antagonist for PsAhttps://practicaldermatology.com/news/fda-approves-novartis-cosentyx-as-first-iv-formulation-il-17a-antagonist-for-psa/2462048/The US Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Novartis’ Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx
- FDA Approves Arcutis’ ZORYVE (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11https://practicaldermatology.com/news/fda-approves-arcutis-zoryve-roflumilast-cream-03-for-treatment-of-psoriasis-in-children-ages-6-to-11/2462045/The U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) to expand the indication of ZORYVE (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children ages 6 to 11 years. “T
- When Lightning Strikes: A Case Study of Staphylococcal Scalded Skin Syndrome in a 55-year-old Manhttps://practicaldermatology.com/news/when-lightning-strikes-a-case-study-of-staphylococcal-scalded-skin-syndrome-in-a-55-year-old-man/2462042/Five months after being struck by lightning, a 55-year-old male presented with a 2-day history of an erythematous rash. The patient noted his skin had been excessively dry since the lightning strike, and he recently added a new essential oil to his bath. His medical history includes liver failure
- AD Pipeline Update: FDA Rejects Lilly’s Lebrikizumab Due to Third-Party Manufacturing Issueshttps://practicaldermatology.com/news/ad-pipeline-update-fda-rejects-lillys-lebrikizumab-due-to-third-party-manufacturing-issues/2462037/The U.S. Food and Drug Administration (FDA) did not approve Eli Lilly's lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis due to findings during an inspection of a contract manufacturer. The letter cited findings
- Cabaletta Bio Receives FDA Clearance of IND Application for Treatment of Systemic Sclerosis with CABA-201https://practicaldermatology.com/news/cabaletta-bio-receives-fda-clearance-of-ind-application-for-treatment-of-systemic-sclerosis-with-caba-201/2462036/The U.S. Food and Drug Administration (FDA) is allowing Cabaletta Bio, Inc.’s third Investigational New Drug (IND) application for CABA-201 to proceed. for a Phase 1/2 study in patients with systemic sclerosis (SSc). CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell
- FDA Approves Merz Aesthetics’ Belotero Balance (+) for Infraorbital Hollowshttps://practicaldermatology.com/news/fda-approves-merz-aesthetics-belotero-balance-for-infraorbital-hollows/2462028/The U.S. Food and Drug Administration (FDA) approved Merz Aesthetics’ Belotero Balance (+) for improvement of the infraorbital hollow (IOH) in adults over the age of 21. This approval stems from positive pivotal study results demonstrating the efficacy and safety o