(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the US FDA for venglustat, an investigational oral drug targeting neurological symptoms of type 3 Gaucher disease, a rare genetic disorder with no approved treatments for its neurological manifestations. The designation … Read the full press release →
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged biotechnology, clinical trials, enzyme replacement therapy, Fast Track Designation, FDA, Gaucher disease type 3, GD3, imiglucerase, Karin Knobe, LEAP2MONO, lysosomal storage disorder, orphan drug, rare disease, Sanofi, Sanofi Strengthens Pipeline with Venglustat Following FDA Breakthrough Designation for Rare Neurological Disorder, US Food and Drug Administration, venglustat
(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the U.S. FDA and orphan drug designation from Japan’s Ministry of Health, Labour and Welfare for rilzabrutinib (Wayrilz) in warm autoimmune hemolytic anemia, based on data from the ongoing LUMINA 2 … Read the full press release →
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Retail, Science, Security & Safety, Technology
Tagged Breakthrough Therapy, BTK inhibitor, clinical trials, FDA, FDA Grants Breakthrough Status to Sanofi’s Rilzabrutinib for Rare Blood Disorder, IgG4-related disease, immune thrombocytopenia, Japanese Ministry of Health Labour and Welfare, Karin Knobe, LUMINA 2, LUMINA 3, orphan drug, rare diseases, rilzabrutinib, Sanofi, Sanofi Advances Rilzabrutinib with Breakthrough and Orphan Designations in wAIHA, sickle cell disease, Tailored Covalency®, wAIHA, warm autoimmune hemolytic anemia, Wayrilz
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