|Articles|December 18, 1996

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.

Related to this article

Foundation Model-Based Chest X-Ray AI Software Gets FDA Nod
Reportedly one of the first FDA-cleared chest X-ray AI software platforms derived from a foundation model, the Chest Xray software facilitates detection and localization of lung nodules, pneumothorax, mediastinal abnormalities and other thoracic abnormalities.
Does kV Still Matter in Photon-Counting CT?
Emerging research demonstrates the increasing stability of attenuation on clinically relevant VMIs with photon-counting CT and a redefined role of kV that may have implications for longitudinal quantitative CT.