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Advisers to the FDA back COVID vaccines for the youngest children
By: Scott Hensley | NPR
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WASHINGTON, D.C. (NPR) — A committee of advisers to the Food and Drug Administration voted unanimously to recommend that the agency authorize COVID-19 vaccines from Moderna and Pfizer-BioNTech for children as young as 6 months. The committee’s recommendations, in a pair of 21-0 votes, pave the way for the FDA to make COVID-19 vaccines available… Read More
The FDA OKs another Pfizer or Moderna COVID booster for people 50 and up
By: Associated Press
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WASHINGTON, D.C. (AP) — U.S. regulators are allowing people 50 and older to get another booster dose of the Pfizer or Moderna COVID-19 vaccine. The Food and Drug Administration’s decision aims to offer extra protection to the most vulnerable in case the virus rebounds. The FDA said Tuesday that age group can seek a fourth dose… Read More
The FDA postpones a highly anticipated meeting on the Pfizer vaccine for young kids
By: Scott Hensley | NPR
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WASHINGTON, D.C. (NPR) — A highly anticipated meeting of expert advisers to discuss whether to recommend the use of the Pfizer-BioNTech COVID-19 vaccine for young children has been postponed. The Food and Drug Administration said Pfizer told the agency that new data have recently emerged regarding its emergency use authorization request for the Pfizer vaccine… Read More
COVID-19 vaccine for young kids could be ready this month
By: Peter Granitz | Rob Stein | NPR
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Updated February 1, 2022 at 7:42 AM ET WASHINGTON, D.C. (NPR) — The last age group of the population unable to get a Covid-19 vaccine may soon be able to do so — and much earlier than anticipated. Pfizer-BioNTech is expected to file a submission for emergency use to the Food and Drug Administration for… Read More
FDA authorizes a Pfizer booster shot for children ages 12 to 15
By: Scott Hensley | Joe Hernandez | NPR
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Updated January 3, 2022 at 10:41 AM ET WASHINGTON, D.C. (NPR) — The Food and Drug Administration has authorized the use of a Pfizer-BioNTech booster in adolescents 12 to 15 years old. The agency on Monday also shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose… Read More
FDA authorizes 1st antiviral pill for COVID
By: Scott Hensley | NPR
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WASHINGTON, D.C. (NPR) — In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home. The pill, called Paxlovid, is made by Pfizer. It’s taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral. “Today’s authorization introduces the… Read More
The FDA authorizes COVID booster shots for all U.S. adults
By: Scott Neuman I NPR
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WASHINGTON, D.C. (NPR) — The Food and Drug Administration has given its OK for fully vaccinated Americans who are age 18 and older to receive a COVID-19 booster shot. The FDA on Friday granted emergency use authorization for a third dose of the Pfizer-BioNTech and Moderna vaccines, which had already been available to people 65… Read More
FDA authorizes use of Pfizer’s COVID vaccine for 5- to 11-year-olds
By: Joe Neel | NPR
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WASHINGTON, D.C. (NPR) — The Food and Drug Administration has authorized a Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11. This lower-dose formulation of the companies’ adult vaccine was found to be safe and 90.7% effective in preventing COVID-19. The agency acted Friday after a panel of independent scientists advising the FDA strongly supported… Read More
Pfizer Officially Asks The FDA To Authorize Its COVID Vaccine For Kids Aged 5-11
By: Joe Hernandez | NPR
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Updated October 7, 2021 at 9:27 AM ET WASHINGTON, D.C. (NPR) — Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11. Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to… Read More
Pfizer Submits Favorable Initial Data To The FDA On Kids’ COVID-19 Vaccine Trial
By: Bill Chappell | NPR
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WASHINGTON, D.C. (NPR) — Pfizer and BioNTech are another step closer to seeking authorization for young children to receive the COVID-19 coronavirus vaccine, submitting data to the Food and Drug Administration that shows a “robust” antibody response and “favorable” safety outcomes in kids ages 5 to 11 who received the two-dose regimen in clinical trials…. Read More
The FDA Has Approved A New Alzheimer’s Drug — Here’s Why That’s Controversial
By: Scott Hensley | Jon Hamilton | Laurel Wamsley | NPR
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This is the first new drug approved for Alzheimer’s disease since 2003. It’s the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer’s disease.
US Panel Endorses Widespread Use Of Pfizer COVID-19 Vaccine
By: Associated Press
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WASHINGTON (AP) — A U.S. government advisory panel has endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. The group, in a 17-4 vote with one abstention, concluded… Read More
Pfizer To Seek FDA OK For COVID-19 Vaccine ‘Within Days’
By: Joe Palca | NPR
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The vaccine was found to be 95% effective in an updated study analysis. Safety data required by the Food and Drug Administration showed no serious concerns, the company said.
Web Of ‘Wellness’ Doctors Promote Injections Of Unproven Coronavirus Treatment
By: Tom Dreisbach | NPR
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An NPR investigation has identified a web of more than 30 medical practices and compounding pharmacies in over a dozen states that have made claims about thymosin alpha-1 online and on social media.
9 Drugmakers Sign Safety Pledge In Rush To Develop Coronavirus Vaccine
By: Bill Chappell | NPR
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The pledge comes one month after a survey found that only 2 in 5 Americans said they planned to get vaccinated against COVID-19.
‘Meaningless’ FDA Certificates Are Used To Tout Dubious Face Masks
By: Sydney Lupkin | NPR
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Companies that made hats, socks and teddy bears have started producing surgical masks to protect people from COVID-19. Some sellers exaggerate their standing with the Food and Drug Administration.
FDA Withdraws Emergency Use Authorization For Hydroxychloroquine
By: Joe Palca | NPR
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Emergency use authorization makes it easier for doctors to use a drug in a manner not specifically approved by the Food and Drug Administration. The FDA granted these drugs this status in March.
FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test
By: Joe Neel | Hannah Hagemann | NPR
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The test has been promoted by the Trump administration as a key factor in controlling the epidemic in the U.S. and is used for daily testing at the White House.
DeWine Calls For Federal Help With Testing Materials
By: Associated Press
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COLUMBUS, Ohio (AP) — Governor Mike DeWine is calling on the federal government to help provide crucial materials that would allow a dramatic increase in testing for coronavirus in his state — and later reported a “very positive” response from the agency concerned. Gov. DeWine said Sunday on NBC’s “Meet the Press” that Ohio hospitals… Read More
FDA Seeks To Expand Treatment For Coronavirus As Part Of White House Response
By: Philip Ewing | Franco Ordoñez | NPR
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President Trump spoke about the effort during a briefing at the White House. He also expressed interest in the government possibly taking an equity stake in companies as part of a big stimulus.
While FDA Warns CBD Companies, Ohio Valley Industry Continues to Grow
By: Liam Niemeyer | Ohio Valley ReSource
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The U.S. Food and Drug Administration sent out 15 letters last week warning some companies that sell cannabidiol, or CBD, about making unfounded medical claims regarding the effects of the hemp-derived compound. Many users claim CBD has a wide range of medicinal benefits but there is little evidence. Despite this warning, the burgeoning industry in the Ohio Valley continues… Read More
FDA Commissioner Scott Gottlieb Announces He Will Resign
By: Laurel Wamsley I NPR
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Gottlieb, who will resign in a month, stood out in the Trump administration for his efforts to regulate the tobacco and pharmaceutical industries. The reasons for his resignation are not yet clear.
Too Much Vitamin D In Dog Food May Have Poisoned Pets, Spurring Recalls And FDA Alert
By: Amy Held | NPR
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The FDA says pet owners should watch out for vitamin D toxicity. Recalled brands include Abound, Nutrisca and Natural Life.
FDA Seeks Ban On Menthol Cigarettes To Fight Teen Smoking
By: Rob Stein | NPR
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In its latest effort to curb smoking by young people, the FDA wants to outlaw menthol cigarettes. The agency would also restrict sales of flavored e-cigarettes to reduce youth addiction to nicotine.