Incyte Says FDA Declines Supplemental Biologics Application for Zynyz Injection

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Incyte (INCY) said in a Friday filing that the US Food and Drug Administration did not approve the supplemental biologics application for an additional indication of its Zynyz injection for the treatment of adult patients with metastatic non-small cell lung cancer, combined with platinum-based chemotherapy.

The company said a Feb. 27 complete response letter from the FDA cited certain inspection findings related to Catalent Indiana, the third-party fill-finish facility in the application, as the "sole approvability issue."

Catalent Indiana is a part of Novo Nordisk and Incyte said it is working with the facility and the FDA to address the matter. The FDA's letter did not cite any other concern in the application, the company added.

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The FDA's letter did not cite any other concern in the application, the company added.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00BKVL7J92.USD","symbol_name":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2618647578","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2618647578","pubTimestamp":1773052186,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. 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