U.S. FDA declines to approve Revance's frown-line treatment [Financial Post (Toronto, Ontario, Canada)]
AbbVie Inc. (ABBV)
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Source: Financial Post
injectable drug to treat moderate to severe frown lines, sending its shares plunging 29%. The company said the FDA pointed to “deficiencies” related to the regulator's inspection of Revance's manufacturing site. Series A for start-ups: what entrepreneurs should know before launching their business Advertisement No other concerns were raised in the agency's “complete response letter,” the drug developer said. Revance's DaxibotulinumtoxinA for Injection, a potential rival for AbbVie Inc's Botox anti-wrinkle injection, was successful in reducing moderate to severe frown lines in a late-stage study in December 2018. Advertisement Article content In November last year, the U.S. FDA delayed its decision on the drug, as it was unable to conduct required inspection of the company's manufacturing facility due to COVID-19 travel restrictions. Revance later said it was expecting approval in 2021. “We are very disappointed by this unanticipated response from the FDA and are seek
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ABBV
Earnings
- 2/2/24 - Beat
ABBV
Sec Filings
- 4/3/24 - Form 8-K
- 4/2/24 - Form 4
- 4/2/24 - Form 4
- ABBV's page on the SEC website