FDA issues CRL to Astellas' IZERVAY sNDA for geographic atrophy

By Yahoo! Finance | Nov 20, 2024 at 04:34 AM EST

The FDA issued a complete response letter for Astellas Pharma's IZERVAY sNDA due to statistical concerns about proposed labelling language, not safety or efficacy. Astellas aims to address the issues promptly and update the prescribing information based on positive trial outcomes.

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