Rezolute Gets FDA Recommendation For Pre-BLA Meeting Ahead Of Ersodetug BLA Submission For Congenital Hyperinsulinism Treatment.
The Agency reiterated its commitment to addressing the unmet need for treatment of congenital and tumor-related hyperinsulinism and to serving these patient communities On track to report topline results for the Phase 3
Rezolute got approval from the FDA to move forward with their new medicine. This means the company is on track and the FDA wants to help find treatments for this rare disease.
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