The setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration...
U.S. drug regulators rejected Eli Lilly & Co.’s proposed new Alzheimer’s disease treatment, saying they need more data from clinical testing, according to the company.
The... U.S. drug regulators rejected Eli Lilly & Co.’s proposed new Alzheimer’s disease treatment, saying they need more data from clinical testing, according to the company. The FDA issued a so-called complete-response letter to Lilly for the company’s application for a speedy FDA approval of the drug, called donanemab, Lilly LLY said Thursday.
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