source
- 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 · 13d 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 · 13d ago↗ source
- Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitorMerck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.