Pharmacyclics agent cleared in U.K.
Pharmacyclics of Sunnyvale, CA, has received regulatory approvalin the U.K. for its Gadolite oral MRI contrast agent, which isindicated for diagnosing pelvic and abdominal disorders. Gadolitewill be marketed in the U.K. and the rest of Europe by E-Z-EMof
Pharmacyclics of Sunnyvale, CA, has received regulatory approvalin the U.K. for its Gadolite oral MRI contrast agent, which isindicated for diagnosing pelvic and abdominal disorders. Gadolitewill be marketed in the U.K. and the rest of Europe by E-Z-EMof Westbury, NY, under a deal between the two companies announcedthis month. E-Z-EM will file marketing applications for Gadolitein additional European countries under the European Union's mutualrecognition process.
E-Z-EM also has rights to Gadolite in the U.S., Canada, andMexico. A new drug application for Gadolite was filed with theFood and Drug Administration in September, according to the companies.Gadolite is manufactured by Glaxo Wellcome.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
