“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry,” Makary said at the ...

Prasad has vocally criticized the Warp Speed effort, and Marks’ leadership, on his blog and the social media platform X, where he was often praised by now-FDA Commissioner Dr. Marty Makary for ...

The U.S. Food and Drug Administration (FDA) approved on Friday additional color ... The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015.

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA ...

The Food and Drug Administration (FDA) announced Tuesday it will be moving to take ingestible prescription fluoride products for children off the market, citing concerns that the mineral alters ...

No use of the drug has received FDA approval as it can result in serious harm or death, Makary clarified. He emphasized the public must address the trend before it becomes the latest example of ...

Prasad replaces Dr. Peter Marks, who served as the director of the Center for Biologics Evaluation and Research at the FDA and played a key role in launching Operation Warp Speed — the Trump ...

Seven weeks later, the FDA named Marks’ successor: Dr. Vinay Prasad, a hematologist and oncologist. That wouldn’t necessarily be a notable development from a political perspective, except ...

The FDA is seeking public input on Operation Stork Speed, a review of and effort to improve the quality of infant formula. Health and Human Services Secretary Robert F. Kennedy Jr. says the ...

The US Food and Drug Administration (FDA) and OpenAI have reportedly been discussing a potential partnership that seeks to use artificial intelligence in drug evaluations of the agency.

Not all people should take Fujirebio's new test. The FDA says that it is "intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline" and is ...