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 ...

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 ...

MRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC.

The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.