Structural and informational barriers drive nonrepresentative trial cohorts; aligning enrollment with catchment demographics and collaborating across centers improves generalizability and equity.

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...

FDA proposes using a well-supported mechanistic rationale plus natural history comparators to generate substantial evidence when randomized trials are infeasible for ultra-rare populations.

Compass Pathways has announced that its investigational psilocybin treatment has successfully met its primary endpoint in a second Phase 3 clinical trial moving it one step closer to FDA submission.

LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the pricing of ...

COMP360 shows rapid symptom improvement in depression study COMP360 may compete with J&J's Spravato if approved Compass plans FDA meeting for rolling submission Feb 17 (Reuters) - Compass Pathways ...

Painting Pathways Clubhouse in Manitowoc has appointed Gabriella Thiel as its new interim director. Thiel previously served as the organization's clubhouse coordinator and was unanimously supported by ...

INDIANAPOLIS – In a unanimous vote, the Indiana House of Representatives passed House Bill 1277, a piece of legislation aimed at overhauling the state’s embattled PathWays for Aging Medicaid program.

This article is the latest in the Health Affairs Forefront featured topic, “Health Policy at a Crossroads,” produced with the support of the Commonwealth Fund and the Robert Wood Johnson Foundation.