logo
Plus   Neg
Share
Email

FDA Seeks Addl Information To Complete Review Of HyQ BLA - Quick Facts

Baxter International Inc. (BAX) and Halozyme Therapeutics Inc. (HALO) announced that the U.S. Food and Drug Administration is requesting additional information to complete its review of the HyQ Biologics License Application or BLA.

Baxter and Halozyme said that they 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. The companies now 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 the companies' anticipated regulatory review and approval timeline.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amazon.com Inc. (AMZN) Thursday reported a first-quarter profit that more than doubled from a year ago, driven largely by a huge 46 percent growth in revenues. Shares of the online retailer gained 6 percent in extended session. Seattle, Washington-based Amazon reported first-quarter profit of $1.63... Software giant Microsoft Corp. (MSFT), Thursday reported an increase in profit for the third-quarter that trumped analysts' estimates, driven largely by strong growth in cloud business, as the software giant continues its transition from key software business to cloud business. Redmond, Washington-based... Shares of Deutsche Bank were losing around 2 percent in German trading after the banking giant reported lower profit and revenues in its first quarter with weakness in all segments, mainly Corporate & Investment Bank. Separately, the bank announced actions to reshape its Corporate & Investment Bank and additional cost-cutting measures, including job cuts.
Follow RTT