Advanced Magnetics’ bid to expand the labeling of MRI liver contrast agent Feridex I.V. has failed. The FDA has declared the company’s supplemental new drug application “not approvable.” Advanced Magnetics had hoped to increase
Advanced Magnetics’ bid to expand the labeling of MRI liver contrast agent Feridex I.V. has failed. The FDA has declared the company’s supplemental new drug application “not approvable.” Advanced Magnetics had hoped to increase the appeal of Feridex, which has floundered in the marketplace, by including differentiation of liver lesions as benign or metastatic and changing the dosing regimen to allow more rapid infusion. The agent, which was originally approved by the FDA on Aug. 30, 1996, is marketed in the U.S. by Berlex Laboratories, a subsidiary of Schering of Germany.
What a New Meta-Analysis Reveals About PET/CT Radiotracers for csPCa
February 6th 2025The PET/CT agent 18F-PSMA-1007 offered the highest surface under the cumulative ranking curve (SUCRA) out of nine radiotracers at the patient and lesion level for detecting clinically significant prostate cancer (csPCa), according to a meta-analysis.
New CT Angiography Study Shows Impact of COVID-19 on Coronary Inflammation and Plaque
February 5th 2025Prior COVID-19 infection was associated with a 28 percent higher progression of total percent atheroma volume (PAV) annually and over a 5 percent higher incidence of high-risk plaque in patients with coronary artery lesions, according to CCTA findings from a new study.