FDA Says No to Accelerated Approval for Alzheimer’s Drug
The US Food and Drug Administration (FDA) has denied accelerated approval for the investigational anti-amyloid donanemab (Eli Lilly) for the treatment of early Alzheimer’s disease (AD) because of insufficient data, the manufacturer has announced. In a press release, the company reported the FDA issued a complete response letter requesting that Lilly provide data from at least 100 patients who received […]
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