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- FDA pauses voucher program as Eli Lilly's GLP-1 weight-loss drug cleared in China; experts see AI aid for device regulationThe U.S. Food and Drug Administration announced it is shelving the commissioner's voucher program, effectively pausing the incentive that speeds up review of certain products. Eli Lilly secured ap…
- EMA seeks industry input on draft guideline for biomarker-guided therapy approvalsThe European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…