However, the FDA found these responses inadequate to address the violations. The agency has requested a written response within 15 working days, including a revised HACCP plan, five consecutive ...

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. FDA Commissioner Marty Makary, M.D., and Center for Biologics ...

After weeks of signaling a shift in thinking, the new leaders of the FDA and the agency’s division that regulates vaccines published a commentary in the New England Journal of Medicine laying ...

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain ...

The FDA said in a news release it will conduct a scientific review of the children's products by Oct. 31 with the aim of removing them from the market. It is not immediately clear whether the ...

The test is for older Americans already exhibiting signs of Alzheimer's. The Food and Drug Administration (FDA) cleared the first blood test on Friday to help diagnose Alzheimer's disease.

Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older. But late Friday ...

The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that it can help reduce the need for invasive samples or expensive PET scans.

In a statement, FDA Commissioner Martin Makary said 10% of people aged 65 and older have Alzheimer's. "I am hopeful that new medical products such as this one will help patients," Makary said.

May 19, 2025 – The FDA has approved the Novavax COVID-19 vaccine, a protein-based alternative to mRNA shots, with some limits on who can get it. The vaccine, called Nuvaxovid, is mainly ...

The Food and Drug Administration (FDA) has approved Starjemza ® (ustekinumab-hmny), a biosimilar to Stelara ® (ustekinumab), for the treatment of various chronic inflammatory diseases.