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In April, Ms. Pisano became the second person to receive a kidney transplant from a genetically modified pig. Hers was a particularly complicated case: she suffers from heart and kidney failure and she received the organ only eight days after receiving a mechanical heart pump. Ms. Pisano was at risk of dying without a heart pump, a device implanted in patients who need a heart transplant. But there is a critical shortage of available human donor kidneys, and her heart disease has made her ineligible to receive one. She is the first known heart pump patient to receive an organ…

What is the framework for approval? In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. Status, the recognition of a drug's therapeutic promise, aims to shorten regulatory times. The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity, Lykos Therapeutics, to commercialize MDMA if it gained approval. FDA approval. The request presents an unusual challenge for the FDA, which typically does not regulate drug treatments associated with talk therapy, an essential part of Lykos' regimen for treating post-traumatic stress disorder. On June 4, an expert advisory panel will…