logo
Share SHARE
FONT-SIZE Plus   Neg

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 RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Senate Republicans appear poised to approve a budget resolution that will serve as the legislative vehicle for their tax reform plan. The non-binding budget resolution unlocks the reconciliation process, allowing Republicans to pass their tax reform plan with a simple 51-vote majority in the Senate. President Donald Trump intends to nominate antitrust attorney Joseph Simons as chairman of the Federal Trade Commission, the White House announced on Thursday. Simons, who served as an FTC official under President George W. Bush, is currently a partner and co-chair of the antitrust group at law firm Paul Weiss. Less than four months after its debut on the New York Stock Exchange, Blue Apron Holdings Inc. said it is laying off 6 percent of its workforce. In a regulatory filing on Wednesday, the embattled meal-kit delivery company said it has implemented a company-wide realignment of personnel to support its strategic priorities.
comments powered by Disqus
Follow RTT