Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway

Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway

Government acceptance initiates formal regulatory review of Entolimod under Ukraine's Regulatory Equivalency pathway, with a potential review expected in as few as 45- to 60-days.

Ukraine MoH Accepts Valion Bio’s Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway - BioTuesdays

Valion Bio (NASDAQ: VBIO) has announced that the regulatory dossier for its lead candidate, Entolimod for acute radiation syndrome (ARS), has been accepted by Ukraine’s Ministry of Health (MoH) for formal review under the country’s Regulatory Equivalency pathway.  Entolimod represents a paradigm shift in the treatment of ARS. Growth-factor therapies currently held in the U.S. Strategic National Stockpile — such as Neupogen (filgrastim) and Neula…