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Advanced Magnetics submits NDA for Combidex
Contrast agent supplier Advanced Magnetics has submitted a new drug application (NDA) to the Food and Drug Administration for Combidex, an MRI contrast agent. The company’s European marketing partner, Guerbet, has also submitted the European
Contrast agent supplier Advanced Magnetics has submitted a new drug application (NDA) to the Food and Drug Administration for Combidex, an MRI contrast agent. The companys European marketing partner, Guerbet, has also submitted the European equivalent of an NDA to the European Medicines Evaluations Agency. Combidex is Advanced Magnetics third product.
The companys U.S. NDA covers two indications: the diagnosis of lymph node disease and the detection, diagnosis, and evaluation of benign and malignant lesions of the liver and spleen. Advanced Magnetics hopes to receive priority review from the FDA for its Dec. 21 application, which would precipitate an action letter from the FDA six months from the application date rather than 12. Guerbet expects to launch Combidex in Europe in early 2001 under the trade name Sinerem.
The company hopes Combidex will help oncologists and radiologists to noninvasively stage metastatic cancer in lymph nodes. Advanced Magnetics plans to find a marketing partner for the agent, according to the Cambridge, MA-based firm.
Can Portable Dual-Energy X-Ray be a Viable Alternative to CT in the ICU?
September 13th 2024The use of a portable dual-energy X-ray detector in the ICU at one community hospital reportedly facilitated a 37.5 percent decrease in chest CT exams in comparison to the previous three months, according to research presented at the American Society of Emergency Radiology (ASER) meeting in Washington, D.C.
New Meta-Analysis Examines MRI Assessment for Treatment of Esophageal Cancer
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Study for Emerging PET/CT Agent Reveals ‘New Standard’ for Detecting Clear Cell Renal Cell Carcinoma
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Can Radiomics and Autoencoders Enhance Real-Time Ultrasound Detection of Breast Cancer?
September 10th 2024Developed with breast ultrasound data from nearly 1,200 women, a model with mixed radiomic and autoencoder features had a 90 percent AUC for diagnosing breast cancer, according to new research.
