Astellas Pharma (JP:4503) has released an update.
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Astellas Pharma received a Complete Response Letter from the FDA regarding its supplemental New Drug Application for IZERVAY, a treatment for geographic atrophy linked to age-related macular degeneration. The FDA’s concerns are not about the drug’s efficacy but rather a statistical issue with the proposed labeling. Astellas is working to address these comments and evaluate potential financial impacts.
For further insights into JP:4503 stock, check out TipRanks’ Stock Analysis page.
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