The U.S. gave the final go-ahead Friday to Pfizer's COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.
As expected, a Food and Drug Administration (FDA) advisory panel has recommended Emergency Use Authorization (EUA) for the Pfizer/BioNTech Covid-19 vaccine in the United States. This clears the way for FDA approval of the vaccine within days. Once approved by the FDA, Pfizer will deliver hundreds of millions of doses over the coming months. The […]
The United States should be celebrating a day of great hope today, as a Covid-19 vaccine could get authorized for emergency use very soon.
Regeneron's antibody drug, given to President Trump after he contracted the coronavirus, got an emergency use authorization from the FDA.
It’s pretty easy when you have vaccines that are 95% effective. Can’t get much better than that. I think what people need to appreciate — and that’s why I have said it like maybe 100 times in the last week or two — is the process by which a decision is made. The company looks at the data. I look at the data. Then the company puts the data to the FDA. The FDA will make the decision to do an emergency use authorization or a license application approval. And they have career scientists who are really independent. They’re not beholden to anybody. Then there’s another independent group, the Vaccines and Related Biological Products Advisory Committee. The FDA commissioner has vowed publicly that he will go according to the opinion of the career scientists and the advisory board.
The FDA has approved the first drug to treat COVID-19: remdesivir, an antiviral medicine which previously was authorized only for emergency uses. Here's the latest virus news.
The EUA program, established in 2004, gives the U.S. Food and Drug Administration the power to grant temporary, accelerated approval to a medical drug or device needed in a public health emergency. The EUA review process is less rigorous than a regular approval.
A COVID-19 vaccine would need to prevent or decrease the severity of the disease by 50% or more, according to FDA guidelines. FDA Commissioner Stephen Hahn has repeatedly stressed that the agency won’t cut corners.
By: Julie Loffredi, National Lifestyle Content Desk Dr. Elina Berglund Scherwitzl is the co-founder and CEO of Natural Cycles, a new FDA cleared birth control app. In this Q&A, Dr. Elina talks about how her personal experience helped set in motion the new technology that...
TRUMP: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” — tweet Saturday.
The agency says overuse on farm animals can lead to drug resistance