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- Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuriesAxiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
- Experts say MDUFA VI draft letter improves program while addressing FDA resource limitsIndustry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…