Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade BAX now with 

Baxter International Inc. (BAX: Quote) 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.

Click here to receive FREE breaking news email alerts for Baxter International Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Stocks moved notably higher over the course of the trading day on Friday after initially showing a lack of direction. The gains on the day extended the recent upward trend by the markets, with the tech-heavy Nasdaq reaching its best closing level in almost a month. Looking to capitalize on news of an Ebola diagnosis in New York City, Republican Senate candidate Scott Brown issued a statement Friday criticizing his Democratic opponent Sen. Jeanne Shaheen, D-N.H., for "waffling" on a travel ban. In another troubling sign for Democrats, the results of a Gallup poll released on Friday show that Tea Party Republicans are much more motivated to vote in the upcoming midterm elections than other Americans. The poll found that 73 percent of Tea Party Republicans are "extremely" or "very" motivated to vote in this year's elections.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.