FDA hits Hutchmed, Junshi drugs with CRLs — further clarifying its stance on China-only data - Endpoints News

The FDA is firmly shutting the door to China-only data when it comes to approving new cancer drugs — with some exceptions. Just over a month after hitting Eli Lilly and Innovent’s sintilimab with a complete response letter, the agency sent back Hutchmed’s NDA…

As the FDA’s urgency around pandemic-related activities begins to recede, the agency has been on a tear over the past week in releasing new drug-related guidance documents, with 8 new ones, including… [+434 chars]

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