Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

FDA Has Granted Priority Review To NDA For Regorafenib, Reveals Onyx Pharma

Onyx Pharmaceuticals Inc (ONXX: Quote), a global biopharmaceutical company, and Bayer Healthcare Pharmaceuticals Inc, have, on Thursday, jointly announced that the U.S Food and Drug Administration or the FDA, has granted priority review designation to the New Drug Application, or the NDA, for the oral multi-kinase inhibitor regorafenib.

The company further stated that Bayer Healthcare had filed the NDA at the end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies.

The company stated that Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Onyx Pharmaceuticals further added that the FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Furthermore, the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

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

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
With trading resuming following the long, holiday weekend, stocks showed a lack of direction throughout the trading session on Tuesday before ending the day mixed. The markets largely held on to the bulk of their recent gains. The Islamic State (IS), a Sunni extremist group previously known as Islamic State of Iraq and the Levant (ISIL), has released a video purporting to show the beheading of US journalist Steven Sotloff, media reports said Tuesday. According to reports, the video also showed a masked man threatening to execute a British man named David Haines. He also warned governments to stay away "this evil allian Less than a month after resigning from Congress, former House Majority Leader Eric Cantor, R-Virg., has made the move from Washington to Wall Street by joining boutique investment bank Moelis & Co. A statement from Moelis said Cantor will serve as Vice Chairman and Managing Director and also be elected to the company's Board of Directors.
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.