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

The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...

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

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

The controversial appointment of oncologist Vinay Prasad — an outspoken ... Now, as the director of the Center for Biologics Evaluation and Research, which oversees vaccines, gene therapies ...

The FDA has launched a pilot program using generative AI to help expedite the review of drug and device applications, part of a sweeping modernization effort by the agency. The initiative, led by FDA ...

Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the ...

Health and Human Services Secretary Robert F. Kennedy Jr. said on Thursday that the U.S. drugs regulator would look for ways ...

Leaders from the world of cell and gene therapy shared their personal stories and policy recommendations in an extraordinary ...

This Viewpoint, by Vinay Prasad, MD, MPH, of the Center for Biologics Evaluation and Research, Food and Drug Administration, and ...

HHS Secretary Robert F. Kennedy Jr. said that the FDA would look for ways to fast-track approval for rare disease treatments ...

Fears about the FDA imposing steep barriers to gene therapies for rare diseases appeared moot at an agency roundtable ...