For a cancer-focused digital startup, FDA rejection meant the end of the road

Plus: A controversial approval for Novocure's device

October 18, 2024 Check out STAT+

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Adobe STAT+ | For this cancer-focused digital health startup, an FDA rejection meant the end of the road Blue Note's failure to clear the FDA hurdle offers a rare window into the regulatory challenges faced by digital therapeutics companies. By Mario Aguilar Amy Abernethy, former No. 2 at FDA, outlines new company's plans to streamline clinical research Abernethy said her new company, Highlander Health, is making its first grants to help streamline evidence generation and shorten clinical trials. By Lizzy Lawrence A controversial approval for Novocure's device Today's biotech news updates include a controversial approval for Novocure, and how Martin Shkreli got Mark Cuban into the drug world. By Elaine Chen Sarah Gonzales for STAT Their research may be transformative. They worry patients won't be able to access it Three of this year's STAT Wunderkinds are working to translate research into innovative ways to diagnose diseases. By Anil Oza

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