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- Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemiaAmylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
- FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reformThe U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…