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FDA Recommends Withdrawal of Approval for Breast Cancer for Avastin

January 3, 2011
The US FDA announced on December 16 that it is recommending removal of the breast cancer indication from the label for Avastin (bevacizumab) from Roche because the analysis of post marketing clinical data collected as an approval condition failed to…

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Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Shinya Sato

The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…

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By Ken Yoshino

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Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…