FDA “Unable” To Act On Hylenex By User Fee Deadline
This article was originally published in The Pink Sheet Daily
Executive Summary
Approval of Halozyme Therapeutics’ hyaluronidase product could be bogged down by ongoing legal arguments over Ista’s Vitrase exclusivity.
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Halozyme Expects Hylenex Exclusivity Issues To Be Resolved Soon
FDA approved Hylenex on Dec. 2 as the first recombinant human hyaluronidase product.
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