FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

ASTCT’s Leadership Contributes to FDA Decision to Eliminate REMS for BCMA- and CD19-Directed Autologous CAR T Cell Immunotherapies ...

Modern Retina provides ophthalmology professionals with the latest advancements, research, and expert insights in retinal ...

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

All requested anonymity due to fear of retaliation from leadership. They told STAT that morale is incredibly low as departures mount and distrust of leaders grows among the staff that remain.

The FDA has eliminated a safety monitoring requirement and eased certain restrictions that had been in place since CAR T-therapies first reached the market in 2017. The agency and financial ...