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Regulatory UpdatesAug 23, 2026•1 min read

PMDA Approves SHINSA CDx for Identifying Eligible Patients

By the PharmaCountry team

Japan’s PMDA has approved the SHINSA companion diagnostic (CDx) to help identify patients eligible for specific therapies, updated June 16, 2026.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced that the SHINSA companion diagnostic (CDx) has received approval for use in identifying patients who are eligible for certain treatments. The approval was updated on June 16, 2026. Further details are available on the PMDA website.

Compiled by the PharmaCountry team · Source: PMDA Japan

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