US Pharma MarketingAs FDA momentum grows for psilocybin, insurers assess how longer supervised sessions and REMS obligations may increase liability compared with Spravato. Formal approval may not arrive within the 12-month window Secretary Robert F. Kennedy Jr. predicted in June 2025 , but several of the enabling regulatory steps are falling into place. Compass Pathways, whose synthetic psilocybin COMP360 hit its primary endpoint in two Phase 3 trials for treatment-resistant depression, is now filing its new drug application on a rolling basis after the FDA granted that request in April . The agency also awarded COMP360 a Commissioner’s National Priority Voucher ,…
More than five decades after the Controlled Substances Act that President Richard Nixon signed in 1970 placed psilocybin in Schedule I, the same tier as heroin and reserved for drugs the federal government deemed to have no accepted medical use, the compound is on the verge of becoming the first classic psychedelic to win FDA…
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Source: Drug Discovery & Development