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 The FDA unveiled draft guidance on a proposed ...

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 ...

The FDA has released draft guidance outlining an approval pathway for individualized therapies aimed at ultra-rare diseases, building on a framework first outlined by agency leaders in November. The ...

Multi-omics profiling of residual cancer burden after neoadjuvant hormonal therapy guides subtype-directed treatment in high-risk and locally advanced prostate cancer. Predictive associations between ...

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.

French President Emmanuel Macron has unveiled updates to France's doctrine on the potential use of nuclear weapons, marking what he described as a new phase in the country's deterrence strategy.