FDA's ODAC shrugs off objections to Mesoblast's GVHD drug for children, voting 9-1 in favor and improving the odds of an approval
The FDA’s Oncologic Drugs Advisory Committee once again waved through an investigational drug, clearing the potential final hurdle before the agency’s decision.
Thursday’s winner was Mesoblast $MESO, an Australian stem-cell company that submitted its Ryoncil drug for the treatment of steroid refractory acute graft-versus-host disease in children younger than 12. ODAC gave Ryoncil the thumbs up by a 9-1 vote, shrugging off concerns about trial design and pushing aside the need for an additional study.
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