Rezolute Announces FDA Recommendation to Hold a Pre-BLA Meeting as a Precursor to Submitting a Biologics License Application (BLA) for Congenital Hyperinsulinism
Rezolute announced that the FDA has recommended holding a pre-BLA meeting, a precursor to submitting a Biologics License Application for the treatment of congenital hyperinsulinism. The Agency reiterated its commitment to addressing the unmet need in congenital and tumor-related hyperinsulinism and to serving those patient communities.
Why it matters — This signals regulatory progress toward a potential BLA submission for RZLT's congenital hyperinsulinism program.