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- Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rulesIndustry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
- Researchers create mouse with human-derived brain cortex, sparking ethical and scientific debateA research team led by Stanford professor Sergiu Pașca has reported in Nature the creation of a laboratory mouse whose cerebral cortex is built from human brain cells derived from stem cells. The s…