Australian startup Biomebank, known for its world-first regulatory approval of fecal microbiota transplants, is raising $4 million to develop a lab-grown gut therapy aimed at the U.S. market. Founder Sam Costello shared that initial feedback from the FDA on their cultured therapy has been positive, with clear manufacturing parameters established. However, Biomebank’s U.S. expansion faces regulatory uncertainty as potential reforms under Elon Musk’s Department of Government Efficiency (DOGE) and shifting political dynamics, including RFK Jr.’s influence, create an unclear future for FDA oversight.
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