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- FDA urges validation of digital health endpoints and clear missing-data plansFDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
- Alumis' TYK2 lupus drug fails mid-stage trial, CEO says clear path forwardAlumis announced that its TYK2 inhibitor did not meet primary endpoints in a mid-stage study in patients with lupus. The trial, which was the company's lead program, was designed to evaluate effic…