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The Food and Drug Administration approves the first over-the-counter contraceptive pill, the Perrigo-manufactured Opill, broadening access to birth control across the country.
2023-07-13

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

A Food and Drug Administration official says that a vaccine for children under the age of 12 years is expected to be approved by midwinter.
2021-07-15

Moderna says that their vaccine is 100% effective in teenagers between the ages of 12 and 17. They say that they will seek approval from the U.S. Food and Drug Administration in early June.
2021-05-25

The U.S. Food and Drug Administration bans the usage of seven artificial flavors as food additives. Six of them cause cancer in animals when used in "much higher" doses than the conditions of their intended use.
2018-10-6

The United States Food and Drug Administration (FDA) lifts the 32-year-old, lifetime ban on blood donations from gay and bisexual men. Men can donate if they haven't had sex with another man in the previous year. The FDA stance is in line with other countries, such as Australia, Brazil, Canada, New Zealand, and the U.K., and is consistent with rules on recent blood transfusion or accidental exposure to another individual's blood.
2015-12-21

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 U.S. Food and Drug Administration (FDA) approves Provenge (sipuleucel-T), the first "vaccine" approved to treat cancer, for men with advanced prostate cancer.
2010-04-29