At least 58,000 childern younger than 5 years old are hospitalized each year with RSV infections. A Pfizer vaccine given to pregnant people could help protect their infants from severe RSV illness.

A panel of experts voted 8-6 in favor of Food and Drug Administration approval of the first gene therapy for Duchenne muscular dystrophy, a fatal genetic disease.

While the number of people eligible to donate blood has expanded, the agency says it will continue to monitor the safety of the blood supply.

In a unanimous vote, 17-0, a panel of advisers to the Food and Drug Administration recommended that the agency approve the first over-the-counter birth control pill.

The Food and Drug Administration is weighing whether to allow a birth control pill to be sold over the counter for the first time. An advisory committee opens a two-day hearing Tuesday.

A recent report finds that banning menthol and flavored cigarettes would eliminate disparities in lung cancer death rates between Black Americans and other racial groups within the next five years.

GenBioPro, which makes a generic form of mifepristone, is suing the FDA seeking to preserve access to the drug amidst ongoing federal litigation.

Supreme Court Justice Samuel Alito has placed a hold on a lower court ruling that restricts access to the abortion drug mifepristone until Wednesday night.

A Texas judge ruled that the Food and Drug Administration wrongly approved mifepristone in 2000 and accused it of doing a rush job. Here's what really went down.

The Biden administration had asked the higher court to stay a decision from a Texas judge while the appeal plays out.

The drug had been fast-tracked for approval under the agency's accelerated approval program, and has been available for more than a decade, despite the drugmaker's failure to prove that it works.

The Food and Drug Administration appears poised to make available the COVID-19 vaccines that target omicron as a second booster for people with weak immune systems and those ages 65 and older.

The White House is working with private companies like DoorDash and Instacart to try to make healthy food more accessible. It also named Olympic athletes to a council focused on nutrition.

The 20 states where Walgreens won't sell mifepristone include some where abortion remains legal. It's not clear whether other retail pharmacies will follow suit.

The Food and Drug Administration has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.