Rocket Pharmaceuticals Announced The FDA Has Extended The Priority Review Period For Kresladi Application For Severe Leukocyte Adhesion Deficiency-I, By Three Months To June 30, 2024
Author: Benzinga Newsdesk | February 13, 2024 08:27am
The FDA extended the review period by three months, to June 30, 2024, to allow additional time to review clarifying Chemistry, Manufacturing, and Controls (CMC) information submitted by Rocket in response to FDA information requests. The FDA has further confirmed that an advisory committee meeting is not needed.
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