Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.
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Explore the 20 CRLs issued to biggest pharma firms since the start of 2021 with Pink Sheet infographic describing US FDA’s concerns and current status.