Baxter International Inc. (BAX: Quote) and Halozyme Therapeutics, Inc. (HALO: Quote) announced that the U.S. Food and Drug Administration, or FDA, is requesting additional information to complete its review of the HyQ Biologics License Application, or BLA.
Both the companies will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. At present, the companies expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data. The companies expect these requests to require additional time to complete and to delay their anticipated regulatory review and approval timeline.
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by RTT Staff Writer
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