FDA Oncology Center of Excellence during COVID-19

What The Viewpoint Says: This Viewpoint discusses initiatives of the U.S. Food and Drug Administration’s Oncology Center of Excellence to address COVID-19-related challenges faced by patients with cancer and the health care professionals who provide cancer treatment. Authors: Jennifer J. Gao, M.D., of the Oncology Center of Excellence at the FDA in Silver Spring, Maryland, is […]

FDA approves genetically engineered pigs for food and transplants

Pigs that have been genetically engineered to be free of a molecule that triggers meat allergies have been approved by the Food and Drug Administration (FDA). On Monday (Dec. 14), the agency approved these swine, known as GalSafe pigs, for both human food consumption and potential therapeutic purposes, such as use in xenotransplantation (or transplants […]

The FDA has authorized Pfizer’s COVID-19 vaccine. Now what?

Millions of Americans will soon be lining up for COVID-19 shots.  On December 11, the Food and Drug Administration granted emergency use authorization for the Pfizer-BioNTech vaccine for those age 16 and older. The decision comes as numbers of COVID-19 cases, hospitalizations and deaths have been rising at alarming rates. The United States recorded a […]

The FDA just green-lit America’s first COVID vaccine

This is just the first vaccine to be approved in the US. (Pexels/) Follow all of PopSci’s COVID-19 coverage here, including the truth about herd immunity, advice for pregnant women, and a tutorial on making your own mask. The FDA just announced that Pfizer will get an Emergency Use Authorization (EUA) to distribute its COVID-19 […]

Experts recommend Pfizer’s COVID-19 vaccine to FDA for emergency use

The benefits of Pfizer-BioNTech’s COVID-19 vaccine outweigh its risks for emergency use in those 16 and older in the United States, a panel of vaccine experts told the Food and Drug Administration on December 10. The recommendation followed a daylong meeting the panel, the Vaccines and Related Biological Products Advisory Committee, held to discuss data […]

The FDA says Pfizer’s COVID vaccine is effective and safe

Experts will meet to review the vaccine on Thursday. (Unsplash/) The Food and Drug Administration (FDA) released an analysis of pharmaceutical company Pfizer’s COVID-19 vaccine data on Thursday morning. According to the report, the FDA has no specific concerns that would prevent authorization of the vaccine. Pfizer’s vaccine has not yet received an Emergency Use […]

FDA approves the first drug for progeria, a rapid-aging disease

The U.S. Food and Drug Administration has approved a treatment that could give children with a rare genetic illness that causes premature aging more time to live. Children with the disease, known as Hutchinson-Gilford progeria syndrome, or progeria for short, often die of heart failure, heart attack or stroke as teenagers. Most children with the […]

The WHO and FDA are at odds over remdesivir

Over 50 million American plan on traveling for Thanksgiving. (Camila Perez/) As health officials have been warning for months, the cold weather and holiday season have resulted in intense, widespread spikes in COVID-19 infections across the country. The US saw one million new cases last week, and that number is expected to continue climbing as […]

Pfizer vaccine is 95% effective, company to seek FDA approval within days

The coronavirus vaccine developed by Pfizer and BioNTech is 95% effective at preventing COVID-19, the companies announced Wednesday (Nov. 18). They plan on seeking regulatory approval “within days.” Last week, Pfizer announced that an early analysis revealed its vaccine to be more than 90% effective at preventing an infection, greatly exceeding public health experts’ expectations, […]

FDA authorizes 1st fully at-home COVID-19 test

The Food and Drug Administration (FDA) has authorized the first fully at-home rapid COVID-19 test. The test, made by Lucira Health in California, requires a prescription and provides results within 30 minutes, according to a statement from the FDA. Although the FDA has authorized hundreds of COVID-19 tests (including at-home tests), these earlier tests either […]