Celison (CLSN) Meets FDA Requirements for New Drug Application Submission
Celsion Corp. is a leading oncology drug development company focused on treatments using heat energy and heat-activated drug delivery systems. The company today announced it has come to an agreement with the U.S. Food and Drug Administration (FDA) that acknowledges that the company has met requirements for non-clinical studies for its New Drug Application (NDA) for ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin applicable for the treatment of a wide range of cancers. ThermoDox is currently being evaluated in a 600-patient phase III study at 75 clinical sites to evaluate the drug’s efficacy in combination with radiofrequency ablation (RFA).…