FDA Qualifies Total Hip BMD as Regulatory Endpoint for Entera Bio's Osteoporosis Drug Development

Reuters
2025.12.23 13:30
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Entera Bio Ltd. announced the FDA's qualification of total hip bone mineral density (BMD) as a regulatory endpoint for osteoporosis drug development, marking a significant advancement. This decision allows a streamlined regulatory pathway for new treatments, with Entera Bio's EB613 candidate supported by a single Phase 3 study. This milestone is expected to accelerate drug development and improve access to novel therapies.