The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients died, the drug’s manufacturer halted dosing under pressure from the FDA.

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

Food and Drug Administration Commissioner Marty Makary said in a recent interview he has no plans to change policies ...

Food and Drug Administration Commissioner Marty Makary said he has “no preconceived plans” to change the policies on mifepristone, an abortion pill that ends pregnancy before 10 weeks, in an interview ...

Li, Huang, and Sirota chose 2 cancer drugs out of the top 5 drug candidates for laboratory testing. They predicted one drug, ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to ...