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
Shares of Netflix Inc. (NFLX), Monday gained over 8 percent in extended trading session after the online-video streaming service reported a fourth-quarter profit that trumped analysts estimates, driven largely by higher-than-expected subscriber additions both domestically and internationally. Netflix... American Airlines (AAL) Wednesday announced that it has launched a new Basic Economy fares. The basic economy fares will go on sale in February in 10 markets, with the fares to be expanded to other additional markets later this year. However, not every American Airlines flight will offer basic economy... Chuck E. Cheese pizza and arcade chain's parent company is planning for an IPO, reported Reuters. The public offering would be probably in the second half of 2017. According to the report, the chain has initiated discussions with banks, however has not yet hired any underwriters. The offering would help the restaurant chain for a valuation of around $1 billion.
comments powered by Disqus
Follow RTT