logo
Share SHARE
FONT-SIZE Plus   Neg

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

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Chipotle Mexican Grill Inc. (CMG) on Monday reported a surge in profit for the first quarter, as revenues climbed 20 percent on new restaurant openings and strong same-restaurant sales. Earnings for the quarter trounced Wall Street expectations, but revenues fell short of estimates, hurt largely... Yahoo reported a plunge in profit, hurt by lower prices for display ads as well as one-time charges. Its results fell short of Street estimates, denoting the challenges CEO Marissa Mayer faces in implementing her turnaround plans at the Internet company. Amgen Inc. (AMGN) on Tuesday reported a surge in profit for the first quarter, as revenues grew 11 percent on better pricing and strong demand with research costs falling. Both earnings and revenues for the quarter trumped analysts' estimates. Moving ahead, the drug maker raised its outlook for the full...
comments powered by Disqus
Follow RTT