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News 2026-10-05 11:01 UTC

Rezolute Receives FDA Recommendation for Pre-BLA Meeting

Rezolute has been recommended by the FDA to hold a Pre-Biologics License Application (BLA) meeting. This meeting is a precursor to submitting a BLA for its treatment for congenital hyperinsulinism. The agency reaffirmed its commitment to addressing the unmet medical needs for congenital and tumor-related hyperinsulinis