(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
LONDON, 29-Mar-2016 — /EuropaWire/ — GlaxoSmithKline plc (LSE/NYSE:GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala® (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately … Read the full press release →
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