The FDA has granted orphan-drug designation to Enlivex Therapeutics' Apocell, an experimental drug for graft-versus-host disease. The designation will give the drug seven years of market exclusivity and "significant regulatory easements, which we believe will shorten marketing approval of the drug in the US, reducing costs," Enlivex CEO Alon Moran said.
Enlivex's GVHD drug Apocell wins orphan status from FDA
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