Orchard Starts Filings with FDA for MLD Gene Therapy
Orchard Starts FDA MLD Gene Therapy Filings Orchard Therapeutics has announced they have filed the first module of their rolling BLA with the US FDA for OTL-200, the gene therapy approved as Libmeldy in Europe. The BLA is a “Biologics License Application” that will be reviewed by the FDA. A “rolling BLA” allows Orchard to file the application in multiple parts, which …
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