近日,FDA向再生元发出了另一封完整回复函(CRL),拒绝批准其预填充注射器版本的HD Eylea(8 mg aflibercept)的补充上市申请(sBLA)。原因是其制造商—诺和诺德旗下一家名为的Indiana工厂存在未解决的问题。目前,再生元寻求另一家替代灌装厂来生产HD Eylea的“预填充注射器”,公司预计在2026年1月向FDA提交“替代灌装厂”的相关资料,中间预计需要4个月的审查期。...
Source Link近日,FDA向再生元发出了另一封完整回复函(CRL),拒绝批准其预填充注射器版本的HD Eylea(8 mg aflibercept)的补充上市申请(sBLA)。原因是其制造商—诺和诺德旗下一家名为的Indiana工厂存在未解决的问题。目前,再生元寻求另一家替代灌装厂来生产HD Eylea的“预填充注射器”,公司预计在2026年1月向FDA提交“替代灌装厂”的相关资料,中间预计需要4个月的审查期。...
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