Japan & United States — Food and Drug Administration
9 shared events · Importance 8 · Last updated Jun 17, 2026
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Regulatory
Japan: PMX is approved for therapeutic use in Japan, demonstrating its established presence in international markets.
United States — Food and Drug Administration: The United States — Food and Drug Administration completed its filing review and formally filed Spectral Medical's Premarket Approval application for PMX, initiating the substantive review phase.
Jun 25, 2026 · 6 articles
Business
Japan: The acquired manufacturing platform supplies into multiple global markets including Japan, indicating its international reach and regulatory compliance with Japanese standards.
United States — Food and Drug Administration: The acquired facilities have completed multiple United States — Food and Drug Administration inspections with clean results, indicating compliance with regulatory standards.
Jul 02, 2026 · 7 articles
NEWSDESK
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