Eli Lilly & Co. undefined said Thursday it received a complete response letter (CRL) from the U.S. Food and Drug Administration regarding its Biologics...
Eli Lilly & Co. said Thursday it received a complete response letter from the U.S. Food and Drug Administration regarding its Biologics License Application for its treatment for non-small cell lung cancer. The CRL says the FDA can't approve the BLA for sintilimab in its present form, and includes a recommendation for an additional clinical study. The drug maker is assessing the next steps for sintilimab in the U.S.
... Eli Lilly & Co. LLY said Thursday it received a complete response letter from the U.S. Food and Drug Administration regarding its Biologics License Application for its treatment for non-small cell lung cancer. The CRL says the FDA can't approve the BLA for sintilimab in its present form, and includes a recommendation for an additional clinical study. The drug maker is assessing the next steps for sintilimab in the U.S.
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