(IN BRIEF) AstraZeneca has secured FDA approval for a new subcutaneous autoinjector version of Saphnelo, enabling once-weekly self-administration for adults with systemic lupus erythematosus. The approval is based on Phase III trial results showing significant reductions in disease activity compared … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anifrolumab, AstraZeneca, AstraZeneca introduces new subcutaneous Saphnelo delivery method to improve convenience and outcomes in lupus care, autoimmune disease, autoinjector, biologic therapy, Bristol-Myers Squibb, clinical trials, FDA, Healthcare Innovation, Louise Vetter, Lupus Foundation of America, Medarex, Ruud Dobber, Saphnelo, SLE, Susan Manzi, systemic lupus erythematosus, TULIP-SC, U.S. Food and Drug Administration
(IN BRIEF) Roche has received FDA approval for Gazyva/Gazyvaro (obinutuzumab) as a treatment for adult patients with active lupus nephritis, supported by data from the NOBILITY and REGENCY trials that showed significantly improved renal response compared with standard therapy. The … Read the full press release
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged anti-CD20 monoclonal antibody, autoimmune disease, autoimmune therapy, biopharmaceuticals, CHMP, European Medicines Agency, FDA approval, Gazyva, Gazyva/Gazyvaro Approved by FDA as First Anti-CD20 Therapy to Achieve Complete Renal Response in Lupus Nephritis, Gazyvaro, kidney disease, Levi Garraway, Louise Vetter, Lupus Foundation of America, lupus nephritis, nephrology, NOBILITY trial, obinutuzumab, REGENCY trial, renal response, Roche, Roche Basel, Roche Strengthens Autoimmune Portfolio with FDA Approval of Gazyva/Gazyvaro for Lupus Nephritis Treatment, systemic lupus erythematosus
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