Advaxis Receives FDA Response To Orphan Drug Filing (Medical News Today)
Advaxis, Inc. (OTCBB:ADXS) received the FDA letter late on June 1 denying the company's request for Orphan Drug Designation (ODD) for the use of ADXS11-001 in invasive cervix cancer. The FDA stated their market definition for invasive cervical cancer prevalence (including all those who had been cured) is over the 200,000 person cutoff.

Biotech Calendar: Key FDA Action Dates (TheStreet.com)
A quick and dirty guide to upcoming FDA approval dates for biotech drugs.