(IN BRIEF) Sanofi’s Tzield has been accepted for priority review by the U.S. Food and Drug Administration to expand its use to children aged one year and older with stage 2 type 1 diabetes. The submission is supported by interim … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autoimmune disease, beta cell protection, Christopher Corsico, clinical development, disease modifying therapy, FDA priority review, pediatric diabetes, pediatric endocrinology, PETITE T1D study, regulatory review, Sanofi, Sanofi’s Tzield Receives FDA Priority Review for Use in Young Children with Stage 2 Type 1 Diabetes, stage 2 T1D, teplizumab mzwv, type 1 diabetes, TZIELD
(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged 2025 decision, adjuvant, AstraZeneca, breakthrough therapy designation, clinical paradigm shift, durvalumab, early-stage, EFS hazard ratio, event-free survival, FDA priority review, FLOT chemotherapy, gastric cancer, gastroesophageal junction cancer, high unmet need, Imfinzi, Levi Garraway, locally advanced, MATTERHORN Phase III, neoadjuvant, overall survival, Perioperative Immunotherapy, resectable, sBLA, Susan Galbraith
(IN BRIEF) Sanofi’s Dupixent has been granted FDA priority review for the treatment of bullous pemphigoid (BP), a chronic skin disease. If approved, Dupixent would be the first targeted medicine for BP in the U.S., with the FDA’s decision expected … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged bullous pemphigoid, chronic conditions, clinical trial, corticosteroid, disease remission, Dupixent, Dupixent sBLA, FDA approval, FDA priority review, orphan drug designation, regulatory news, Sanofi, skin disease, targeted treatment
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