FDA

The first vaccine to protect infants from respiratory syncytial virus, or RSV, moved a step toward approval by the Food and Drug Administration with positive votes Thursday from a panel of experts.

Health & Safety

FDA advisers support approval of RSV vaccine to protect infants

5:53pm May 18, 2023

by Scott Hensley

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.

Queue Listen Now

In a close vote, advisers to the Food and Drug Administration recommended approval of a gene therapy for muscular dystrophy developed by Sarepta Therapeutics.

Health & Safety

FDA advisers narrowly back first gene therapy for muscular dystrophy

6:24pm May 12, 2023

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.

Queue Listen Now

The U.S. is moving to ease restrictions on blood donations from gay and bisexual men and other groups that traditionally face higher risks of HIV. Here, tubes direct blood from a donor into a bag in Davenport, Iowa, on Friday, Nov. 11, 2022.

More gay and bisexual men will now be able to donate blood under finalized FDA rules

8:50pm May 11, 2023

by Jonathan Franklin

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.

An advisory panel to the Food and Drug Administration supported drugmaker Perrigo's application to sell the oral contraceptive Opill without a prescription.

Health & Safety

Advisers to the FDA back first over-the-counter birth control pill

5:13pm May 10, 2023

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.

Advisers to the Food and Drug Administration will make a recommendation about whether the agency should approve the first over-the-counter birth control pill in the U.S.

Health & Safety

The FDA considers first birth control pill without a prescription

5:05am May 09, 2023

by Rob Stein

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.

The drug manufacturer GenBioPro received FDA approval for its generic version of the abortion pill mifepristone — the first dose in a widely-used, two-drug protocol — in 2019.

Generic abortion pill manufacturer sues FDA in effort to preserve access

1:49pm April 19, 2023

by Sarah McCammon

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

Politics & Government

Supreme Court briefly puts on hold lower court's limits on abortion drug mifepristone

8:21pm April 14, 2023

by Ximena Bustillo

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.

Health & Safety

Here's what really happened during the abortion drug's approval 23 years ago

5:01am April 14, 2023

by Sydney Lupkin

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 Justice Department had asked the 5th U.S. Circuit Court of Appeals in New Orleans for an emergency stay of an abortion pill ruling by a federal judge in Texas while the court hears the case.

U.S. appeals court preserves partial access to abortion pill, but with tighter rules

6:33pm April 13, 2023

by Sarah McCammon

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

Queue Listen Now

The U.S. Food and Drug Administration has pulled its approval for an unproven drug intended to prevent premature births.

Health & Safety

FDA pulls the only approved drug for preventing premature birth off the market

2:55pm April 06, 2023

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.