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- 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
- Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood testRoche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.Fierce Biotech · 6h ago↗ source
- Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanismRoche has taken its obesity strategy into uncharted territory via a $190 million upfront payment for a clinical-stage urocortin-2 analog from South Korea’s Hanmi Pharm.