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- FDA’s new leadership aims to restore reliability, but each application remains judged on its dataThe FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
- Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findingsThe FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.Fierce Biotech · 6h ago↗ source