REGULATORY

MHLW Orders Package Insert Revision for Xofigo, Warning of Increased Risk of Death, Bone Fracture with 3-Drug Combination

September 20, 2018
The Ministry of Health, Labor and Welfare (MHLW) ordered on September 18 revisions to package inserts for a number of products including Bayer Yakuhin’s castration-resistant prostate cancer treatment Xofigo Injection (radium (223RA) chloride). A statement that the three-drug combination of…

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REGULATORY

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