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Live News REGULATION FLASH L impact Sep 30, 2026, 12:27 AM UTC

Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging

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Why Did CAPR Stock Jump 20% After-Hours Today? Shares of Capricor Therapeutics (CAPR) surged 20% in after-hours trading on Tuesday as new Hope-3 extension data showed substantially slower upper-limb deterioration in patients wh L impact | REGULATION | Sep 30, 2026, 01:24 AM UTC Telix (TLX) Gets FDA Fast Track for BiPASS Imaging Telix was granted FDA Fast Track designation for its BiPASS pre—biopsy prostate cancer imaging.Material DetailsContext by AI AnalystThis is an early regulatory acceleration step th L impact | REGULATION | Sep 30, 2026, 12:27 AM UTC SEC Settles With Space Development Corp. Over Misrepresentation Claims By Katherine HamiltonThe Securities and Exchange Commission settled charges against Space Development Corp. regarding claims the startup misled investors about the status of its pr L impact | REGULATION | Sep 29, 2026, 11:03 PM UTC DBV Technologies (DBV) Files BLA for Viaskin Peanut Patch in Children 4—7 DBV Technologies submitted a Biologics License Application to the FDA for its VIASKIN Peanut Patch in children aged 4—7 and requested Priority Review. The filing is supported by re L impact | REGULATION | Sep 29, 2026, 10:32 PM UTC DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years Châtillon, France, September 29, 2026DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 YearsDBV L impact | REGULATION | Sep 29, 2026, 10:32 PM UTC DBV submits FDA BLA for VIASKIN Peanut Patch in children aged 4-7 DBV Technologies submitted a BLA to the FDA for its VIASKIN Peanut Patch in children aged 4-7, seeking Priority Review; the FDA previously granted Breakthrough Therapy designation. M impact | REGULATION | Sep 29, 2026, 10:30 PM UTC

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