(IN BRIEF) Rilzabrutinib, an investigational oral BTK inhibitor, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), two rare conditions with no approved treatments. This designation, aimed at addressing unmet … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged BTK inhibitor, clinical trials, FDA, IgG4-RD, IgG4-related disease, immune thrombocytopenia, ITP, multi-immune modulation, orphan drug designation, phase 2a study, phase 2b study, rare diseases, regulatory review, rilzabrutinib, Sanofi, unmet medical need, wAIHA, warm autoimmune hemolytic anemia
(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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