logo
Share SHARE
FONT-SIZE Plus   Neg

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

Onyx Pharmaceuticals Inc (ONXX), 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Best Buy Co., Inc. reported lower profit in its first quarter on the absence of last year's CRT settlement proceeds. However, earnings per share topped market estimates significantly with higher comparable sales. Looking ahead, for the second quarter, the company projects higher comparable sales, and also lifted fiscal 2018 forecast for higher growth.In pre-market, shares were gaining 11.9 percent The Federal Communications Commission or FCC will not take any action against CBS Corp.'s "Late Show with Stephen Colbert" despite receiving thousands of complaints about the talk show comedian's controversial joke about President Donald Trump. The U.S. government filed a civil lawsuit on Tuesday against Fiat Chrysler Automobiles, accusing the automaker of installing software in more than 100,000 diesel vehicles to cheat emission controls. The lawsuit alleges that Fiat Chrysler equipped nearly 104,000 light duty diesel vehicles containing 3.0 liter EcoDiesel engines with software functions that were not disclosed to regulators.
comments powered by Disqus
Follow RTT