Ukraine health ministry accepts Valion Bio Entolimod dossier for regulatory review
VBIO•Entolimod review and manufacturing capacity
Entolimod targets acute radiation syndrome; the review is the first known allied-nation regulatory evaluation of the product.
Valion Bio cited manufacturing capacity of about 1,300,000 doses to support potential government stockpiling.
Ukraine accepts Entolimod dossier for formal review
Ukraine’s Ministry of Health accepted Valion Bio’s Entolimod dossier for formal review under its regulatory equivalence pathway.
A decision could come in 45-60 days, leveraging prior US FDA review work, subject to information requests.
