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- FDA issues complete response letter rejecting Tris Pharma’s narcolepsy candidate; Agenus halts Phase 3 colorectal cancer trialThe U.S. Food and Drug Administration sent Tris Pharma a complete response letter for its experimental treatment for narcolepsy, stating that additional data are required before approval can be con…
- FDA proposes new rule to streamline registration of drug manufacturers' factoriesThe FDA announced a proposed rule aimed at changing how factories that produce drugs for the U.S. market are registered with the agency. The change is intended to simplify the registration process…