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Rezolute Prepares For Potential BLA Filing Of Ersodetug In Congenital HI

Source: Nasdaq

Healthcare & BiotechRegulation & Legislation

The FDA recommended a Type B pre-BLA meeting for Rezolute’s ersodetug, a precursor to submitting a biologics license application for hypoglycemia due to congenital hyperinsulinism. This is a regulatory-process milestone, not a BLA submission or approval.

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