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- FDA's new rare-disease framework faces first test with Capricor's Duchenne therapy decisionThe FDA announced a new "fit-for-purpose" rare disease framework that aims to evaluate therapies based on patient need and realistically attainable evidence. The first real test of the approach wi…
- BIO proposes seven-point plan to keep US biotech ahead of ChinaBIO, a major biotech lobbying organization, released a seven‑part “BioAdvance” action plan aimed at preserving U.S. leadership in biotechnology as China rolls out its own five‑year strategy. The p…