The Food and Drug Administration authorizes the Pfizer–BioNTech COVID-19 vaccine for children between the ages of 5 and 11, becoming the first vaccine to be approved for children in the United States.
The Food and Drug Administration gives full approval to the Pfizer–BioNTech COVID-19 vaccine, becoming the first vaccine in the U.S. to be granted full licensure and thereby giving businesses, schools and universities more confidence to adopt vaccine mandates.
The U.S. Food and Drug Administration says that it has granted priority review for the vaccine developed by Pfizer and BioNTech. A decision on whether to fully approve the vaccine will likely be made within two months.
The Food and Drug Administration approves remdesivir to treat COVID-19 in hospitalized patients. The drug, manufactured by the pharmaceutical company Gilead under the brand name Veklury, is the first fully approved COVID-19 treatment in the United States.
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.
The United States Food and Drug Administration approves marketing of a cooling cap system to reduce hair loss in female breast cancer patients during chemotherapy. The DigniCap scalp cooling system, a product first available in Sweden in the 1990s, produces near-freezing temperatures that make it harder for cancer-fighting drugs to reach and harm hair follicles. [https:--www.usnews.com-news-politics-articles-2015-12-08-fda-clears-cold-cap-to-save-hair-during-breast-cancer-chemo (AP via U.S. News and World Report)] [http:--www.fda.gov-NewsEvents-Newsroom-PressAnnouncements-ucm476216.htm (FDA)] [http:--www.dignicap.com-dignitana-fda-clearance- (DigniCap)]date=August 2019