The FDA has accepted for review Spectrum Pharmaceuticals' response on the experimental cancer drug Zevalin as a Class 1 submission, setting a deadline of September 7 for its final decision. That's the kind of news that investors were looking for. Spectrum's stock surged on the news. The agency had asked for more data from Spectrum [1], which is looking to gain approval to use Zevalin to treat non-Hodgkins lymphoma. Report [2]
Links:
[1] http://www.fiercebiotech.com/story/fda-asks-more-zevalin-info/2009-07-06
[2] http://www.reuters.com/article/governmentFilingsNews/idUSBNG17208020090720