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- FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory reviewThe U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
- Elevar Therapeutics receives FDA approval for Lyrfigtu as second-line treatment for bile duct cancerThe U.S. Food and Drug Administration has approved Elevar Therapeutics' drug Lyrfigtu as a second‑line option for patients with bile duct cancer who meet specific criteria. Bile duct cancer is dia…