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Friday, January 6, 2023

Revance: Application (sBLA) OKd for DAXXIFY for Treatment of Cervical Dystonia

  Revance Therapeutics, Inc.,  (Nasdaq: RVNC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck.1 Revance was provided a Prescription Drug User Fee Act (PDUFA) date of August 19, 2023.

https://www.biospace.com/article/releases/revance-announces-u-s-fda-acceptance-of-supplemental-biologics-license-application-sbla-for-daxxify-daxibotulinumtoxina-lanm-for-injection-for-the-treatment-of-cervical-dystonia/

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