FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s ...

Makary and Prasad also repeat various themes repeatedly visited by Kennedy on his Make America Healthy Again (MAHA) soapbox, ...

The FDA’s accelerated approval pathway plays a vital role, and scrapping it or reversing course on already-approved therapies ...

Last Thursday during a roundtable on stem cell therapies, new FDA Commissioner Marty Makary referred to EBM levels of evidence as an artificial and dogmatic construct. Apparently Dr. David Katz's "mor ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

In 2023 Dr. Vinay Prasad said that scientists who recognized the limitations of randomized-controlled trials (RCTS) were ...

Sarepta Therapeutics ( NASDAQ: SRPT) reported a second fatality from acute liver failure in a patient treated with its gene ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

WEDNESDAY, June 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) says it plans to use artificial ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently ...

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s ...

With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed ...