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The Food and Drug Administration grants emergency use authorization for Pfizer's antiviral COVID-19 oral pill named Paxlovid for at-risk people over the age of 12 years, becoming the first at-home oral treatment to be approved by the FDA.
2021-12-22

Advisers to the Food and Drug Administration vote to reject a wider COVID-19 vaccine booster dose and to only recommend booster doses for people over the age of 65 and people who are at high risk of severe illness.
2021-09-17

President Donald Trump and the Food and Drug Administration (FDA) announce the emergency use authorization of convalescent plasma for COVID-19 patients after days of White House officials suggesting there were politically motivated delays by the FDA in approving a vaccine and therapeutics for the disease that President Trump claims has harmed his re-election chances. The FDA said more than 70,000 patients have been treated with convalescent plasma, but they have not yet obtained enough randomized clinical trial data on convalescent plasma for COVID-19. Some of those trials are underway.
2020-08-23

The Food and Drug Administration issues an emergency use authorization for COVID-19 pool testing.
2020-07-18

United States' Food and Drug Administration commissioner Scott Gottlieb announces his resignation "in the next month".
2019-03-5

The United States Food and Drug Administration announces it has relaxed its official requirements regarding the use of the abortion drug Mifeprex (RU-486). The current guidelines were based on 1990s medical evidence. Changes include reducing the number of physician visits required by abortion-seeking women, reducing drug dosage, and allowing women to take the drug for three weeks longer -- now a total of 70 days.
2016-03-30

The U.S. Food and Drug Administration (FDA) approves the country's first biosimilar drug, Zarxio (Europe: 2009, as Zarzio), made by Novartis. Biosimilars are a relatively new class of drugs designed to pave the way for less expensive versions of the complex biologics drug class, and they are not synthesized from chemicals like other drugs, but are made from living cells. Some well known biologics include Remicade and Enbrel for autoimmune diseases, and Herceptin and Avastin for cancer. Zarxio, used to prevent infection in cancer patients receiving chemotherapy, is a close copy of Neupogen, made by Amgen.
2015-03-6

The U.S. Food and Drug Administration approves Truvada as the first drug shown to reduce the risk of HIV infection.
2012-07-16

The Food and Drug Administration, a U.S. government agency, goes to court to secure supplies of a drug used in lethal injections, which have dwindled since an importation ban.
2012-06-1

A study of Food and Drug Administration and U.S. Department of Agriculture employees shows that the food industry has been successfully withholding information from inspectors and pressuring the government agencies to withdraw or alter policies which promote food safety.
2010-09-13