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Biologics
Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
March 28th, 2009
Isolagen, Inc. (AMEX:ILE) announced that the Company has submitted a Biologics License Application (BLA) for Isolagen Therapy(TM), a novel, first-in-class cellular therapy for the treatment of wrinkles/nasolabial folds, to the U.S. Food and Drug Administration (FDA). The Company's wrinkles/nasolabial folds Phase III trials were conducted under an FDA Special Protocol Assessment. "This BLA submission is a significant regulatory milestone for Isolagen," said Declan Daly, Chief Executive Officer and President of Isolagen. "We believe that the Isolagen Therapy(TM), if approved, would represent a new class of treatment in the facial aesthetic arena whereby patients will...
Source: Law & Health Weekly (2009-03-28)
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