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2024 FDA Issued CRLs
FDA
The FDA issued Complete Response Letters (CRLs) for multiple drug applications in 2024, citing concerns about efficacy, safety, and manufacturing. Learn about the rejected drugs, reasons behind CRLs, and their impact on pharmaceutical companies.
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Next Domestic Big Drug
Astellas
Astellas has secured FDA approval for Zolbetuximab, the first Claudin18.2-targeted antibody for advanced HER2-negative gastric cancer. This breakthrough opens a new market, addressing a critical need in cancer treatment and forecasting substantial sales growth in the coming years.
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