FDA拒绝 Outlook治疗药物眼药, 导致库存下降近70%。 FDA rejects Outlook Therapeutics' eye drug, causing stock to plummet by nearly 70%.

美国食品和药物管理局拒绝了Outlook Therapeutics的应用程序,该应用程序的眼药ONS-5010 (Lytenava) 用于治疗湿与年龄相关的黄斑退化,理由是有效性的证据不足. The FDA rejected Outlook Therapeutics' application for its eye drug ONS-5010 (Lytenava) to treat wet age-related macular degeneration, citing insufficient evidence of effectiveness. 这一决定导致公司股票下跌了将近70%。 The decision caused the company's stock to drop by nearly 70%. 虽然欧洲批准了ONS-5010,但林业发展局建议为今后的批准努力提交更多关于有效性的证实性证据。 While ONS-5010 is approved in Europe, the FDA recommended submitting additional confirmatory evidence of efficacy for future approval attempts.