(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 reached a key regulatory milestone with the FDA’s acceptance of its application for Gazyva/Gazyvaro as a treatment for systemic lupus erythematosus. The submission is based on strong phase III trial data showing significant improvements in disease … Read the full press release →
Posted in Healthcare, Industrial, Pharma & Biotech, Science, Switzerland, Technology
Tagged Albert T. Roy, ALLEGORY study, anti-CD20 therapy, autoimmune disease, B cells, biologics, clinical research, disease activity, FDA, FDA Filing Acceptance Marks Significant Step for Roche in Developing Targeted Therapy for Lupus Patients, Gazyva, Gazyvaro, Healthcare Innovation, immunology, Levi Garraway, lupus nephritis, Lupus Research Alliance, obinutuzumab, Phase III Trial, remission, Roche, Roche Advances New Treatment Option for Lupus as FDA Accepts Filing for Gazyva Based on Phase III Data, SLE, systemic lupus erythematosus, U.S. Food and Drug Administration
Treats Seasonal and Year-round Nasal Allergy Symptoms in Adults and Children Paris, France, 06-8-2013 — /EuropaWire/ — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted 10 to … Read the full press release →
Posted in Business, France, Government, Healthcare, Pharma & Biotech, Science
Tagged allergic rhinitis, Anne Whitaker, Charles Hugh-Jones MD MRCP, Chattem, EURONEXT: SAN, FDA, FDA approval of Nasacort AQ Nasal Spray, George Grofik, Inc., Lori Lukus, Marisol Péron, Nasacort AQ Nasal Spray, Nasacort AQ Nasal Spray over-the-counter use in USA, Nasal Allergy Symptoms, NDAC, Nonprescription Drugs Advisory Committee, NYSE: SNY, OTC medicine, over-the-counter use in the U.S., Sanofi, Sanofi US, Sébastien Martel, triamcinolone acetonide, U.S. Food and Drug Administration, upper respiratory allergies
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