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The Not-So-Far-Out Therapeutic Promise of Psychedelics

Introduction Throughout history, humans have had a complex relationship with psychedelics. For millennia, ancient indigenous cultures used them for spiritual and healing purposes. For example, in 2007, archaeologists in Spain discovered mushrooms found at a burial site dated more than 7,000 years old. The mushrooms found at the site were identified as psilocybin, a type…

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FDA Decision for Sarepta’s Gene Therapy for DMD Sets New Regulatory Precedent

Historic Regulatory Decision for First FDA-Approved Gene Therapy for DMD On June 22, 2023, in a-much anticipated decision, the United States Food and Drug Administration (FDA) granted accelerated approval for Elevidys (also known as SRP-9001), Sarepta’s one-time gene therapy for ambulatory children with Duchenne’s muscular dystrophy (DMD). However, the accelerated approval was limited to the…