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- Sanofi pauses Phase 2 bronchiectasis study of SAR445399 amid new CEO’s portfolio reviewSanofi has halted a Phase 2 trial of its investigational antibody SAR445399 in non‑cystic fibrosis bronchiectasis. The pause was attributed to strategic business reasons linked to an internal portf…
- FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelinesFDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…