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- FDA issues draft guidance to streamline approval of personalized gene therapiesThe FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines. The new framework is intended to speed the development and approval of personalized gene t…
- Karyopharm files for Chapter 11 bankruptcy as it pursues merger with AyrmidKaryopharm Therapeutics has filed for Chapter 11 bankruptcy while seeking a merger with U.K. biotech Ayrmid. The court‑supervised process is intended to provide a financial lifeline for the company…