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Johnson & Johnson Applies for Emergency Use Authorization for COVID-19 Vaccine
Johnson & Johnson says they have applied to the Food and Drug Administration for an emergency use authorization for its coronavirus vaccine.
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FDA Approves 1st Long-Acting HIV Drug Combo, Monthly Shots
U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace daily pills.
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FDA Grants Moderna Vaccine Emergency Use Authorization
The Food and Drug Administration issued emergency use authorization for the Moderna coronavirus vaccine on Friday night.
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FDA Advisory Panel Paves Way for Emergency Use Authorization for Moderna Vaccine
A Food and Drug Administration advisory panel voted 20-0 to recommend emergency use authorization for the Moderna coronavirus vaccine.
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US Regulators OK Genetically Modified Pig for Food, Drugs
U.S. regulators have approved a genetically modified pig for food and medical products, but the company behind it says you won’t see it on supermarket shelves anytime soon.
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FDA Authorizes First Over-the-Counter Coronavirus Test
The FDA announced on Tuesday that it has authorized the first coronavirus test that can be taken at home and without a prescription.
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FDA Approves Coronavirus Vaccine for Emergency Use
The Food and Drug Administration approved an emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine on Friday.
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FDA Not Recommending Vaccine for Pregnant Women Right Now
The FDA’s Dr. Peter Marks said Saturday that pregnant women should consult their doctor before taking the Pfizer vaccine, given that pregnant women were not part of the clinical trials for the emergency use authorization. “The provider and individual can make a decision about whether the benefits outweigh the risks,” said Marks. “[Taking the vaccine is] not something that we’re...
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Panel Recommends Emergency FDA Approval of Pfizer Vaccine
An advisory committee met Thursday and voted in favor of endorsing the Pfizer-BioNTech COVID-19 vaccine for emergency authorization, saying that the benefits outweigh the risks.
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What Does Emergency Use for a COVID-19 Vaccine Mean?
The first COVID-19 vaccines to be given in the U.S. are expected to get a green light from regulators under a process known as emergency use authorization.
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US Allows 1st Emergency Use of a COVID-19 Antibody Drug
U.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19.
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US Regulators Approve 1st Treatment for Ebola Virus
U.S. regulators have approved the first drug for treating Ebola.
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15 Adults Hospitalized After Drinking Methanol-Contaminated Hand Sanitizer. Four Died.
Fifteen adults have been poisoned after drinking hand sanitizer that contained methanol, the Centers for Disease Control and Prevention reported Wednesday. Methanol, or wood alcohol, is a toxic chemical that can lead to hospitalization or death if ingested. The Food and Drug Administration first warned of hand sanitizers with possible methanol contamination in June, citing nine products from Mexico. Since then, the list...
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FDA Warns Against Contaminated Hand Sanitizer
The Food and Drug Administration has issued recalls for 59 hand sanitizers that contain methanol, a toxic chemical that can be fatal if ingested.
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FDA Warns of Possible Toxic Hand Sanitizer
The Food and Drug Administration says nine products produced by Mexico-based Eskbiochem SA de CV may contain methanol, which can be harmful if absorbed through the skin or ingested.
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FDA Approves Video Game for Treating ADHD in Kids
The U.S. Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in children
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FDA Probes Accuracy Issue With Abbott's Rapid Virus Test
Federal health officials are warning about potential accuracy problems with a rapid test for COVID-19 made by Abbott Laboratories.
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FDA Shows New Point-of-Care Coronavirus Test
At a White House coronavirus task force briefing, Dr. Stephen Hahn, commissioner of food and drugs at the FDA, showed a new point-of-care coronavirus test that can give results in about 5 minutes.
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I-Team: Diet Noodles Blamed for ‘Unholy Levels of Gastric Upset and Rage'
According to a doctor, another person ate a single package of the noodles and suffered a 10-day bout of vomiting and nausea — and needed surgery that required using a drill to break up the noodles after forming a gastric obstruction.
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FDA Investigates Link Between Some Pet Foods, Canine Heart Disease
The Food and Drug Administration is investigating a potential link between certain brands of dog food, including Blue Buffalo, Merrick and Rachael Ray Nutrish, and an increased risk of heart disease in pets. The agency is looking into more than 500 cases of canine heart disease, identifying the brands of dog food that have been most frequently fed to pets...