AbbVie Provides Update on TrenibotulinumtoxinE (TrenibotE) Biologics License Application in the U.S.
AbbVie Inc. (ABBV)
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Source: PR Newswire
U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for trenibotulinumtoxinE (TrenibotE) related to manufacturing processes; no additional clinical studies are requested As the leader in neurotoxin development and manufacturing, AbbVie is well positioned to address all comments in a timely mannerNORTH CHICAGO, Ill., April 23, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration. In its letter, the FDA requested additional information about manufacturing processes. The CRL does not identify any safety or efficacy concerns for TrenibotE, and does not request additional clinical studies. AbbVie is confident that it can address the FDA's comments promptly and expects to submit a
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- Drugmaker AbbVie chooses North Carolina for $1.4B manufacturing campus [Yahoo! Finance]Yahoo! Finance
- AbbVie Provides Update on TrenibotulinumtoxinE (TrenibotE) Biologics License Application in the U.S. [TheStreet.com]TheStreet.com
- Spotting Winners: AbbVie (NYSE:ABBV) And Therapeutics Stocks In Q4 [Yahoo! Finance]Yahoo! Finance
- AbbVie (ABBV) was given a new $294.00 price target by Piper Sandler.MarketBeat
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