美国食品药品监督管理局警告生物科技亿万富翁Soon-Shiong,
FDA warns biotech billionaire Soon-Shiong over misleading cancer drug claims.
美国食品药品监督管理局对生物技术亿万富翁帕特里克·苏恩-希昂博士发出警告,
The U.S. Food and Drug Administration issued a warning to biotech billionaire Dr. Patrick Soon-Shiong over misleading claims promoting his company's cancer drug, Anktiva.
该机构引用了一个播客, 宣声称该药物可以治疗,治愈或预防各种癌症, 包括辐射引起的癌症. 这违反了联邦营销规则.
The agency cited a podcast where Soon-Shiong claimed the drug could treat, cure, or prevent various cancers, including radiation-induced ones, violating federal marketing rules.
美国食品和药物管理局还批评该药被标记为"癌症疫苗",并没有披露副作用等风险.
The FDA also criticized the drug's labeling as a "cancer vaccine" and the absence of risk disclosures, such as side effects.
免疫生物公司有15天的时间来回应并纠正问题,导致该公司股票大幅下跌.
ImmunityBio was given 15 days to respond and correct the issues, resulting in a significant drop in company stock.