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Fda Withdrawal

All articles tagged with #fda withdrawal

healthcare7 months ago

Daiichi and Merck Withdraw Lung Cancer Drug Filing After Survival Data Miss

Merck and Daiichi Sankyo have voluntarily withdrawn their BLA for HER3-DXd, a drug for NSCLC, after phase 3 trial results failed to meet survival endpoints and discussions with the FDA. Despite previous promising data, the drug's development faces setbacks, but the companies remain committed to ongoing research across multiple cancer types.