Tag Archives: FDA

The US Food and Drug Administration on Monday fully approved Pfizer’s COVID-19 vaccine, a move expected to trigger a new wave of vaccine mandates as the delta variant batters the country. “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA …

The US FDA is warning against the use of animal medications for human COVID-19 infections after multiple people were hospitalized after taking ivermectin, a treatment intended for horses. “There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19,” the food and drug administration …

France said on Thursday it failed to understand why it was exempt from a new rule allowing fully-vaccinated European Union citizens to enter England without having to quarantine. From next week, travelers fully jabbed with a vaccine approved by the US Food and Drug Administration or the European Medicines Agency …

US health officials issue new warnings over rare neurological reactions for people getting the one-shot Johnson & Johnson vaccine. United States regulators have added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction. The Food and Drug Administration (FDA) announced …

Pfizer and BioNTech say that a third COVID-19 booster dose given about six months after the second shot improves vaccine efficacy against new coronavirus variants and that this is backed by initial data from their study on booster shots. While the COVID-19 vaccine remains 95% effective in preventing serious cases, …

The US Food and Drug Administration said on Wednesday it plans to move quickly to add a warning about rare cases of heart inflammation in adolescents and young adults to fact sheets for the Pfizer/BioNTech and Moderna vaccines.

U.S. regulators on Monday approved Biogen Inc’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s disease despite controversy over whether the clinical evidence proves the drug works. Aducanumab aims to remove sticky deposits of a protein called amyloid-beta from the brains of patients in earlier stages …

In what could be a major breakthrough for novel coronavirus testing, the Food and Drug Administration has given emergency authorization for a new kind of saliva-based screening method Saturday, aimed at streamlining how samples are processed and cutting both cost and turnaround time. Developed by Yale’s School of Public Health, …

The mayor of the second-largest U.S. city has joined a growing clamor among health experts and politicians for a radical shift in the nation’s coronavirus testing strategy – from an emphasis on the utmost accuracy to a focus on speed and simplicity. The concept envisions mass production and distribution of …

Vaping and smoking could raise a young person’s risk of developing COVID-19 according to researchers who found 13-24-year-olds who used such products were five to seven times more likely to have the condition caused by the coronavirus. Researchers recruited 4,351 people aged 13 to 24 from the U.S. to complete …

Over 100 people in the U.S. died in the first half of 2020 after taking the anti-malarial medicine hydroxychloroquine or related drugs while sick with COVID-19, according to a report. Analysis of new data from the U.S. Food and Drug Administration’s (FDA) adverse events reporting system by the Milwaukee Journal …

Using hand sanitizer can help prevent the spread of the coronavirus, but overusing a product that contains methanol can cause serious health complications. The Food and Drug Administration warns people not to use more than 90 different hand sanitizers because tests revealed they contain methanol. Methanol is not an “acceptable …

Gilead Sciences, Inc., said on Friday additional data from a late-stage study showed its antiviral remdesivir significantly improved clinical recovery in severely ill COVID-19 patients. Findings from an analysis of its late-stage study showed that 74.4 percent of remdesivir-treated patients recovered by day 14 versus 59 percent of patients receiving …

On Sunday, the head of the U.S. Food and Drug Administration (FDA) declined to criticize President Donald Trump’s unfounded claim that 99% of COVID-19 cases are “totally harmless.” As the United States neared 130,000 deaths from COVID-19 this Independence Day weekend, Trump asserted at a speech yesterday that the U.S. …

The US Food and Drug Administration has revoked its emergency use authorization for the drugs hydroxychloroquine and chloroquine for the treatment of Covid-19. After reviewing the current research available on the drugs, the FDA determined that the drugs do not meet “the statutory criteria” for emergency use authorization as they …

As the world races to produce an effective Covid-19 vaccine, some experts are turning their attention to a polio vaccine as a way to provide temporary protection against coronavirus. There is plenty of evidence that existing inoculations such as polio vaccines protect children against a wide range of infections and …

Nancy Pelosi has said that Donald Trump’s decision to take the anti-malarial drug hydroxychloroquine to prevent Covid-19 was “not a good idea”. Mr. Trump surprised commentators on Monday with the news that he was taking hydroxychloroquine pills in an attempt to prevent infection. That comes despite the US Food and …

Donald Trump has revealed he is taking hydroxychloroquine, a malaria drug he has pushed for weeks as a treatment for coronavirus – even though he has tested negative, and federal health agencies have warned of serious negative side effects for its use. “I take it,” he told reporters. “All I …

The first coronavirus vaccine to be tested in people appears to be safe and able to stimulate an immune response against the virus, its manufacturer, Moderna announced on Monday. The findings are based on results from the first eight people who each received two doses of the vaccine, starting in …

Healthcare giant Johnson & Johnson is looking to produce a billion coronavirus vaccines for next year, according to Dr. Paul Stoffels, the company’s chief scientific officer. “We start clinical trials in September and hopefully have data by the end of the year,” Stoffels said Sunday on ABC, adding that the …