FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.
George F. Tidmarsh has resigned from his job as director of the FDA Center for Drug Evaluation and Research in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.”
