Tag: adverse-events
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Dynavax says FDA rejects its hepatitis B vaccine
(Reuters) – The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling 71 percent in premarket trade. The drug developer said on Monday it received a “complete response letter” from the FDA, seeking information about…
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Mesoblast cell treatment shows promise in rheumatoid arthritis -study
(Reuters) – Mesoblast Ltd on Monday said its experimental stem-cell treatment led to significant improvements of symptoms and disease activity in patients whose rheumatoid arthritis had stopped being helped by widely used biotech medicines, according to data from a mid-stage trial. Treatment with the Australian company’s mesenchymal precursor cell (MPC) product, MPC-300-IV, was deemed well…