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 The FDA unveiled draft guidance on a proposed ...

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.

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 ...

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.