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Thursday, 30 April 2026
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TGA eyes five new drug filings

Posted 30 April 2026 AM

Regulatory pathways handed out by the TGA this month signal five new drugs are on the cusp of being filed in Australia, with new indications for existing therapies also on the cards.

Takeda has received a priority review determination and orphan drug designation for its oral sleep medicine oveporexton, positioning the company to potentially be first to market with an orexin receptor 2 (OX2R) agonist.

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