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 on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency.

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

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory ...

The vaccine advisory committee for the Food and Drug Administration met Thursday to discuss potential changes to the formula for COVID-19 vaccines for 2025-2026.

Expect the FDA to double-down on evidence-based decisions and clear communication of risks/benefits, as this leadership views public trust as essential for biotech innovations to succeed.

Further, there's an industry concern about possible drug policy changes under Makary. Alongside the job cuts, senior FDA leadership has undergone almost a complete makeover.