Kaizen Biosciences Seeks FDA Approval for Pediatric Antibiotic, Plans to Pursue Commissioner’s National Priority Voucher Program.

Kaizen Biosciences has announced multiple abstract acceptances and presented pediatric antibiotic PK data at ISOM. The company is preparing to submit a New Drug Application in September 2025 for its novel amoxicillin-reduced clavulanate formulation. Kaizen is also pursuing the FDA's Commissioner's National Priority Voucher Program, aiming to accelerate the review period and address the public health need for an optimized antibiotic.