United Therapeutics Corporation announced today that the United States Food and Drug Administration , as part of the Biologics License Application approval for Unituxin, awarded United Therapeutics a Rare Pediatric Priority Review Voucher for neuroblastoma, a rare pediatric disease. The voucher can be sold , and the holder of the voucher can redeem it with a subsequently filed New Drug Application or Biologics License Application, requiring FDA to meet the review goals for a priority review, as opposed to a standard review.
http://ift.tt/18yeDCD
http://ift.tt/18yeDCD
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