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- Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approachesTala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel. She says biopharma…
- Sandoz launches direct-to-consumer platform with growth-hormone biosimilar OmnitropeSandoz announced a direct-to-consumer platform, initially offering Omnitrope, a biosimilar growth hormone for growth disorders. The approach follows a trend among brand-name manufacturers to lower…