Showing 1041-1050 of 1539 results for "".
- FDA Accepts sBLA for Interchangeability Designation for Hadlima, a Humira Biosimilarhttps://practicaldermatology.com/news/fda-accepts-sbla-for-interchangeability-designation-for-hadlima-a-biosimilar-to-humira/2462131/The U.S. Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application (sBLA) for the interchangeability designation or Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira(adalimumab). Once a biosimilar product is designated as an in
- Biosimilar News: FDA Approves Stelara Biosimilar Wezlanahttps://practicaldermatology.com/news/biosimilar-news-fda-approves-stelara-biosimilar-wezlana/2462118/The U.S. Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Stelara (ustekinumab) for psoriasis and multiple other inflammatory diseases. The FDA granted the approval of Wezlana to Amgen, Inc. Wezlana, like Stelar
- FDA Approves Cosentyx for HShttps://practicaldermatology.com/news/fda-approves-cosentyx-for-hs/2462109/The US Food and Drug Administration (FDA) has given its nod to Novartis’ Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. The IL-17A inhibitor is the first new biologic treatment option for HS patients in nearly a decade.</
- Biosimilar News: YUFLYMA Added to CarePartners Specialty Pharmacy Cost Savings Programshttps://practicaldermatology.com/news/biosimilar-news-yuflyma-added-to-carepartners-specialty-pharmacy-cost-savings-programs/2462100/Celltrion USA, Inc.’s US Food and Drug Administration-approved biosimilar, YUFLYMA (adalimumab-aaty) has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira (adal
- 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