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AbbVie Faces FDA Rejection On Manufacturing Issues For Wrinkle Drug
AbbVie Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for trenibotulinumtoxinE (TrenibotE), a wrinkle drug. The FDA requested additional information on manufacturing processes but did not cite safety or efficacy concerns, and AbbVie plans to submit a response in the coming months. Separately, AbbVie announced a $1.4 billion investment to build a new pharmaceutical manufacturing campus in North Carolina, focusing on advanced manufacturing and AI integration for its various medicines.