FDA Approves Radiopharmaceutical Diagnostic Agent for Pediatric Patients
June 10th 2021The FDA approved injectable technetium Tc 99m tilmanocept (Lymphoseek), a radiopharmaceutical agent that targets lymphatic mapping and guiding for sentinel lymph node biopsies (SLNB), for use in pediatric patients with melanoma, rhabdomyosarcoma, and other solid tumors.
Age Associated With Survival, Time to Richter Transformation in AYA Patients With CLL
May 30th 2021Age was associated with overall survival and the time to Richter transformation in adolescent and young adult patients with chronic lymphocytic leukemia, according to findings from a single-institutional, retrospective study.
FDA Approves Piflufolastat F 18 PSMA PET Imaging Agent for Prostate Cancer
May 27th 2021The FDA has approved piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.
FDA Grants Priority Review to Maribavir for Post-Transplant Recipients With Cytomegalovirus
May 25th 2021The FDA has accepted a new drug application for maribavir for the treatment of post-transplant recipients with cytomegalovirus infection who are refractory and/or resistant to previous anti-CMV treatment.
FDA Approves Pegcetacoplan for Paroxysmal Nocturnal Hemoglobinuria
May 17th 2021The FDA has approved pegcetacoplan (Empaveli) for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are treatment naïve and those who are switching from the C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris).
AI-Based Focal Therapy System Get a Breakthrough Device Designation for Prostate Cancer Treatment
May 12th 2021The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.