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.
AI Mammography Platform Shows Promising Results for Detecting Subclinical Breast Cancer
October 3rd 2024Mean artificial intelligence (AI) scoring for breasts developing cancer was double that of contralateral breasts at initial biennial screening and was 16 times higher at the third biennial screening, according to a study involving over 116,000 women with no prior history of breast cancer.
CT Study Links Pleural Effusion and Higher 30-Day Mortality Rates in Patients with COVID-19
October 1st 2024In a multicenter study of over 1,100 patients with COVID-19, pleural effusion was detected on CT scans in nearly a third of patients, who also had significantly higher ICU admission and 30-day mortality rates.