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(RTTNews) - Lipella Pharmaceuticals Inc. (LIPO) Tuesday announced FDA's approval for its Investigational New Drug application for clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease.
The clinical study is expected to commence in the second half of 2024. Currently, oral GVHD is a rare but serious oral mucosal disease that currently has no approved therapy.
Earlier, Lipella had received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.
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