FDA BLA Filing Completed for MLD Gene Therapy
FDA Filing Completed for MLD Gene Therapy Orchard Therapeutics requesting Priority Review of BLA Orchard Therapeutics has announced the completion of their BLA filing and a request for Priority Review with the US FDA for OTL-200, the gene therapy approved as Libmeldy in Europe. Their “rolling-BLA” filings started last quarter. The BLA is a “Biologics License Application“, the process used to get an […]