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FDA delays action on Immunomedics agent
Monoclonal antibody developer Immunomedics suffered a blow fromthe Food and Drug Administration last week. The agency's oncologicdrugs advisory committee deferred a decision on the company'sCEA-Scan colorectal cancer imaging agent and recommended thatit
Monoclonal antibody developer Immunomedics suffered a blow fromthe Food and Drug Administration last week. The agency's oncologicdrugs advisory committee deferred a decision on the company'sCEA-Scan colorectal cancer imaging agent and recommended thatit be reviewed by another FDA committee. News of the committee'sdecision caused the Morris Plains, NJ, company's stock to drop26% to $5.75 a share on Oct. 18.
The FDA last year issued Immunomedics a non-approvable letterfor CEA-Scan (SCAN 9/27/95). Immunomedics said it will continueto work with the FDA to receive approval for the agent.
Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI
December 19th 2024In a new study involving nearly 600 biopsy-naïve men, researchers found that only 4 percent of those with negative prostate MRI had clinically significant prostate cancer after three years of active monitoring.
Study Examines Impact of Deep Learning on Fast MRI Protocols for Knee Pain
December 17th 2024Ten-minute and five-minute knee MRI exams with compressed sequences facilitated by deep learning offered nearly equivalent sensitivity and specificity as an 18-minute conventional MRI knee exam, according to research presented recently at the RSNA conference.
Can Radiomics Bolster Low-Dose CT Prognostic Assessment for High-Risk Lung Adenocarcinoma?
December 16th 2024A CT-based radiomic model offered over 10 percent higher specificity and positive predictive value for high-risk lung adenocarcinoma in comparison to a radiographic model, according to external validation testing in a recent study.
