FDA rejects Mesoblast’s cell therapy for bone marrow transplant complications By Reuters

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<span>© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File Photo</span><br />
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<p>(Reuters) – The U.S. Food and Drug Administration had rejected Mesoblast (NASDAQ:)’s cell therapy for children under 12 years of age for treating a type of complication that occurs after a stem cell or bone marrow transplant, the company said on Thursday.</p>
<p>The health regulator required more data to support marketing approval for the company’s lead product remestemcel-L, Mesoblast said in a statement.</p>
<p>The rejection deals a blow to Mesoblast’s hopes for a potential launch of the therapy, especially after its fundraising efforts over the last two years.</p>
<p>The drug developer was seeking the FDA’s approval for a cell therapy to treat children with a type of graft versus host disease (GvHD), whose symptoms did not respond to standard steroid therapy or developed recurrence while continuing treatment.</p>
<p>There are no approved therapies in children for the condition in which the donor bone marrow or stem cells attack the recipient. </p>
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<br /><a href="https://www.investing.com/news/stock-market-news/fda-rejects-mesoblasts-cell-therapy-for-bone-marrow-transplant-complications-3144668">Source link </a></p><p>The post <a href="https://forextraderhub.com/fda-rejects-mesoblasts-cell-therapy-for-bone-marrow-transplant-complications-by-reuters.html">FDA rejects Mesoblast’s cell therapy for bone marrow transplant complications By Reuters</a> first appeared on <a href="https://forextraderhub.com">Forex Trader Hub</a>.</p>