Under the leadership of the U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. and the U.S.

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 ...

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.

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...

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

Dr. Jacqueline Corrigan-Curay, the acting director of the FDA’s Center for Drug Evaluation and Research, internally announced her retirement Monday.

For context, FDA's original "priority review" program negotiated under the PDUFA framework (also instituted by Congress through direct negotiations between the Agency and industry leadership ...

FDA Unveils Voucher Program In Effort To Speed Up Drug Review Time A new program will let drug developers who are "aligned with U.S. national priorities" submit a portion of their applications at ...

President Trump often touted during his first term that his administration had “approved more affordable generic drugs than any administration in history.” He had good reason to highlight ...