Serious Mental Illnesses

Disease

Related News

Compass Pathways highlights FDA Breakthrough designation as Trump orders faster psychedelic reviews

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Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.

Stakeholders Challenge CMS International Reference Pricing Models for Medicare Drugs

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Multiple organizations submitted comments opposing CMS's proposed GLOBE and GUARD models, which would tie Medicare drug reimbursement to international reference prices. Critics argue the models function as price controls that could undermine pharmaceutical innovation.