FDA granted orphan drug designation to ADXS-HPV for the treatment of stage II-IV invasive cervical cancer. ADXS-HPV is an immunotherapy drug candidate, developed by Advaxis Inc., which is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into...
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
