FDA

An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.

FDA Commissioner Robert Califf says a nongovernmental research group will convene experts to deliver the evaluations within 60 business days.

Birth control pills are available in the U.S. only with a prescription. Now a drugmaker is asking the FDA to approve a progestin-only contraceptive that would be available without one at pharmacies.

The U.S. federal agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.

The Food and Drug Administration will have to decide the exact recipe, but a combination shot is expected that adds protection against a version of the omicron variant to the original vaccine.

The company "will finally be held accountable for creating the youth vaping epidemic," the advocacy group Parents Against Vaping e-cigarettes told NPR. Juul said it plans to fight the decision.

As the Food and Drug Administration weighs approval of COVID-19 vaccinations for children under age 5, Florida Surgeon General Joseph Ladapo is opposed to the potential change.

Advisers to the Food and Drug Administration overwhelmingly voted to recommend that it authorize Novavax's two-dose vaccine against COVID-19.

COVID-19 vaccinations for children younger than 5 could start right after the Juneteenth holiday.

The Centers for Disease Control and Prevention's advice opens a third COVID-19 shot to healthy elementary-age kids — just like what is already recommended for everybody 12 and older.

The Food and Drug Administration expanded authorization of Pfizer-BioNTech's COVID vaccine to enable kids ages 5 to 11 who were vaccinated at least five months ago to get a third shot.

Abbott, one of the largest formula makers in the U.S., has reached an agreement with the government to bring a closed factory back on line. And the FDA is easing some restrictions on imported formula.