Angiotech Pharmaceuticals Inc. (ANPI, ANP.TO) announced that it has received correspondence from the FDA regarding its 510(k) submission for Bio-Seal, stating that Bio-Seal is a class III device that requires Pre-Market Approval or PMA for FDA marketing clearance. As a result, Angiotech is reviewing its options with respect to this product candidate, including possibly appealing this FDA decision, and is discussing the possible preparation of a PMA submission with its partner, Biopsy Sciences, LLC.
Should Angiotech elect to continue to pursue development or regulatory approvals for this product candidate that require the company to incur material expense, Angiotech will provide further updates in its public disclosure. Angiotech has not incurred material expense to date with respect to activities regarding this product candidate.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.