food and drug administration

FDA head calls for probe into Alzheimer’s drug review

By Matthew Perrone, Associated Press

Dr. Janet Woodcock announced the extraordinary step via Twitter. It's the latest fallout over last month's approval of Aduhelm, an expensive and unproven therapy that the agency OK'd against the advice of its own outside experts.

Pfizer to seek approval for 3rd vaccine dose, says it could ward off delta variant

By Lauran Neergaard, Associated Press

The company said Thursday that another shot could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant.

FDA trims use of contentious Alzheimer’s drug amid backlash

By Matthew Perrone, Associated Press

The Food and Drug Administration has approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer's drug.

U.S. to resume Johnson & Johnson COVID-19 vaccinations despite rare clot risk

By Lauran Neergaard, Mike Stobbe, Associated Press

Advisers to the Centers for Disease Control and Prevention said Friday the benefits of the single-dose COVID-19 shot outweigh a rare risk of blood clots.

WATCH: FDA committee endorses emergency use for Johnson & Johnson COVID-19 vaccine

By Associated Press

If granted emergency use, Johnson & Johnson's vaccine would be the third available vaccine in the United States, but the first to require one dose rather than two.

FDA approves 1st long-acting HIV drug combo

By Marilynn Marchione, AP Chief Medical Writer

It's expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. Not long ago, patients had to take multiple pills several times a day to control infection with…

Biden taps former FDA head David Kessler to lead COVID-19 vaccine effort

By Ricardo Alonso-Zaldivar, Matthew Perrone, Associated Press

Dr. David Kessler, who will have the title of chief science officer of COVID response, headed the Food and Drug Administration in the 1990s under presidents of both political parties.

FDA dismisses idea of stretching doses by delaying booster shot

By Lauran Neergaard, Associated Press

The first Americans vaccinated against COVID-19 are getting their second dose, while Britain has decided to postpone boosters and focus instead on giving more people a first shot — international differences that are adding to public confusion.

U.S. greenlights first COVID-19 vaccine, launching a nationwide vaccination campaign

By Lauren Neergaard, Matthew Perrone, Associated Press

Shots for health workers and nursing home residents are expected to begin in the coming days after the Food and Drug Administration authorized an emergency rollout of what promises to be a strongly protective vaccine from Pfizer Inc. and its…

Reports: White House threatens Hahn’s job over vaccine approval

By Jonathan Lemire, Darlene Superville, Matthew Perrone, Associated Press

White House chief of staff Mark Meadows has pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer's coronavirus vaccine by the end of Friday or face possible dismissal.