Top officials for the Food and Drug Administration laid out new requirements for access to updated COVID shots, saying they'd continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.
Anti-abortion groups, attorneys general from 25 states and more than 140 members of Congress have signed on to dozens of briefs to the U.S. Supreme Court during the past two weeks, encouraging the justices to revert use and prescribing of the medication abortion pill mifepristone to what was in place prior to 2016.
Postpartum depression affects as many as 1 in 7 women in the U.S., though there are just two treatments approved for it. Experts say the newest could be a game-changer — depending on its price tag.
The Food and Drug Administration is expected to grant full approval to the Alzheimer's drug lecanemab by July 6. But access to the drug may still be limited.
A medical ethics expert says a Texas abortion pill ruling is unprecedented because a federal judge "standing in" for regulators could have far-reaching implications beyond mifepristone.
A federal judge in Amarillo, Texas, on Friday ordered the Food and Drug Administration to rescind its approval for the abortion drug, mifepristone. The ruling was set to go into effect on Friday, but it could be put on hold after the Justice Department filed an appeal on Monday.
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.
An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. A large study found the drug decreased the loss of thinking and memory by 27%.
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 Food and Drug Administration this week approved an injectable drug that helps prevent the spread of HIV. It only has to be taken once every eight weeks, compared to a daily oral pill.
The abortion pill mifepristone was approved in 2000 but still faces layers of restrictions. Advocates want the FDA to permanently allow patients to receive the pill by mail instead of in person.
A panel of independent advisers to the Food and Drug Administration is recommending that the agency issue emergency use authorization for the Pfizer-BioNTech vaccine in children ages 5 to 11 years old.
