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- FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturersThe FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversigh…BioSpace · 15d ago↗ source
- Lilly makes up to $3.8B psychedelics play in AtaiBeckley takeoverWith the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.BioSpace · 15d ago↗ source
- Merck wins first approval of a PCSK9 cholesterol pillThe speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former FDA commissioner Marty Makary.