The FDA has qualified AI-Based Histologic Measurement of MASH, or AIM-MASH AI Assist — the first AI drug development tool — ...

Budget and staffing cuts at the Food and Drug Administration orchestrated by President Donald Trump could prevent new drugs “from being developed, approved, or commercialized in a timely manner, or at ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. DENVER (KDVR) — Gov. Jared Polis recently ...

A rare moment of bipartisan progress has emerged with the Senate’s unanimous passage of the FDA Modernization Act 3.0, ...

Sagimet Biosciences offers a unique play in MASH with Denifanstat, a FASN inhibitor showing both fat reduction and fibrosis regression in Phase 2b. The FDA's acceptance of non-invasive trial endpoints ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market, streamline work at the vast, ...

Significant reforms are necessary in researchers’ relationships with drug regulators and physicians to ensure their discoveries are accessible to those who need them most, according to Janet Woodcock, ...

- U.S. Food and Drug Administration (“FDA”) Commissioner identifies psychedelic drug development as a top agency priority in an effort to address unmet needs in mental health - - Calls for FDA to be ...

Over the last several decades, the Food and Drug Administration has allowed pharma companies to sell hundreds of drugs to patients without adequate evidence that they work and, in many cases, with ...