Oncology Dominates Japan Approvals, Though Overall Tally Is Lower

Although it approved fewer new products last fiscal year, Japan granted access to a number of important new therapies, including in oncology and several for the first time worldwide, helped by continuing reforms at its regulatory body.

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While the number of new active ingredients approved in Japan dipped last fiscal year, a number of important new therapies, notably in oncology, were granted regulatory clearance by the country's expanding regulatory body.

The Pharmaceuticals and Medical Devices Agency (PMDA) approved 39 new active ingredients (including several diagnostics) in the fiscal year to...

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