Missing Mechanism Of Action Dogged Laviv Review
This article was originally published in Pharmaceutical Approvals Monthly
Absence of data about what happens under the surface of the skin when the cell therapy for wrinkles is injected raised safety concerns.
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Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
Fibrocell Provides Final Data To Resolve FDA Concerns On Its Autologous Stem Cell Therapy For Facial Wrinkles
The biotech hopes next to advance its technology into treatment of acne scarring; the laViv PDUFA date is June 22.
An FDA advisory committee made very clear that the bar should be much higher for novel products proposed for aesthetic indications than for drugs to treat diseases during the Oct. 9 review of Fibrocell Science's wrinkle therapy Laviv (azfibrocel-T)