Posts filtered by tags: US Food and Drug Administration[x]


 

FDA's accelerated drug approval process plagued by missing efficacy data and questionable evidence

Since the US Food and Drug Administration established its accelerated approval pathway for drugs in 1992, nearly half of the 253 drugs authorized have not been confirmed as clinically effective, an investigation by The BMJ has found.
Tags: Health, Fda, US Food and Drug Administration


FDA OK's Emergent BioSolutions plant to resume manufacturing J&J's Covid vaccine

Emergent BioSolutions announced Thursday that the US Food and Drug Administration will allow it to resume the manufacturing of the drug substance that goes into Johnson & Johnson's Covid-19 vaccine.
Tags: News, Stories, Fda, Johnson Johnson, US Food and Drug Administration


FDA OK's Emergent BioSolutions plant to resume manufacturing J&J's Covid-19 vaccine

Emergent BioSolutions announced Thursday that the US Food and Drug Administration will allow it to resume the manufacturing of the drug substance that goes into Johnson & Johnson's Covid-19 vaccine.
Tags: Cnn, Fda, Johnson Johnson, US Food and Drug Administration


FDA says it's working as fast as possible to fully approve vaccines, as urgency rises amid Covid surge

The US Food and Drug Administration insists it is working as quickly as possible to review applications for full approval of the Covid-19 vaccines as the number of cases continues to rise and vaccination rates decline across the country.
Tags: Cnn, Fda, US Food and Drug Administration


FDA extends shelf life of J&J vaccine to 6 months, after states remain flooded with millions of nearly expired doses

The US Food and Drug Administration has agreed to extend the expiry date of Johnson & Johnson’s Covid vaccine to six months, pushing it...
Tags: Fda, Johnson Johnson, US Food and Drug Administration


UK coronavirus cases have been dropping dramatically over the past week. Vaccines aren't the only reason.

England removed most of its remaining coronavirus restrictions on July 19. Andrew Milligan - PA Images / Getty The UK reported 25,000 new COVID-19 cases on Monday after a recent peak of nearly 55,000 on July 17. Experts think a combination of warm weather and fewer public gatherings may have helped. The UK's promising trajectory may bode well for the US, where cases are surging. See more stories on Insider's business page. The number of coronavirus cases reported each day in the UK...
Tags: UK, England, Science, London, News, US, Trends, Bbc, United States, Wembley Stadium, United Kingdom, Wembley, Cnbc, Epidemiology, Soho, US Food and Drug Administration


UK coronavirus cases have been dropping dramatically over the last week. Vaccines aren't the only reason why.

The UK economy officially reopened on July 19. Andrew Milligan - PA Images / Getty The UK's daily coronavirus cases dropped to 25,000 on Monday after a recent peak of nearly 55,000 on July 17. Experts think a combination of warm weather and fewer public gatherings may have helped. The UK's promising trajectory may bode well for the US, where cases are surging. See more stories on Insider's business page. The UK's daily coronavirus cases are falling almost quickly as they ro...
Tags: UK, Science, London, News, US, Trends, Bbc, United States, Wembley Stadium, United Kingdom, Astrazeneca, Pfizer, Cnbc, Epidemiology, US Food and Drug Administration, University of East Anglia


COVID: Three states are seeing about 40% of the country’s new cases

By Madeline Holcombe, CNN (CNN) — While Covid-19 cases in the United States have been rising in almost every state over the past week, a handful have been driving the bulk of the nationwide surge. White House coronavirus response coordinator Jeff Zients told reporters Thursday the country has “fundamentally changed the course of this pandemic” and the threat of serious disease and death now is to the unvaccinated. He said counties with the highest case rates have significantly lower vaccination...
Tags: Facebook, Florida, Texas, News, Washington Post, Cdc, White House, US, Alabama, Sport, Cnn, Soccer, United States, Missouri, Arkansas, Delta


The 2nd highest-ranking House Republican just got his first vaccine dose as Mitch McConnell raises alarms about the Delta variant

Kevin McCarthy and Steve Scalise Alex Wong/Getty Images House minority whip Steve Scalise, the second-highest ranking House Republican, revealed that he got his first COVID-19 vaccine dose on Sunday. Scalise previously said he hadn't been vaccinated because he had COVID-19 antibodies. The congressman called the vaccines "safe and effective" and cited the rapidly-spreading Delta variant as a reason for getting vaccinated. See more stories on Insider's business page. House minorit...
Tags: Politics, News, Republicans, Congress, Cdc, Senate, US, Trends, Gop, House, New York Times, Delta, New Orleans, Mitch McConnell, Fda, Louisiana


Federal appeals court vacates FDA rule banning electric shock devices to treat self-harming behavior

A Massachusetts school for individuals with severe behavioral issues and intellectual disabilities can continue to use electric shock devices to stop students from harming themselves and others, a federal court ruled earlier this month, after the US Food and Drug Administration sought to ban such usage in 2020.
Tags: Massachusetts, Cnn, Fda, US Food and Drug Administration


FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine

Pfizer and BioNTech said Friday that the US Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said the decision will come "soon".
Tags: News, Stories, Fda, Pfizer, US Food and Drug Administration, BioNtech


FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine; decision on approval expected by January

Pfizer and BioNTech announced Friday that the US Food and Drug Administration has granted priority review designation to the companies' application for approval of their Covid-19 vaccine. The goal date for a decision from the FDA is January 2022, the companies said.
Tags: News, Stories, Fda, Pfizer, US Food and Drug Administration, BioNtech


FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine; decision on approval expected by January 2022

Pfizer and BioNTech announced Friday that the US Food and Drug Administration has granted priority review designation to the companies' application for approval of their Covid-19 vaccine. The goal date for a decision from the FDA is January 2022, the companies said.
Tags: Cnn, Fda, Pfizer, US Food and Drug Administration, BioNtech


COVID: When there might be a vaccine for younger kids and why it’s taking so long

By John Bonifield | CNN Americans 12 and older can get a COVID-19 vaccine, but younger children are still waiting. With many schools across the United States now just weeks from reopening for the fall semester, pharmaceutical companies Pfizer and Moderna are still doing clinical trials to see how coronavirus vaccines work in children under 12 — if they’re safe and what the right dose should be. Meanwhile, all but four states are seeing an increasing trend in cases, with doctors describing patien...
Tags: Business, Texas, News, Massachusetts, Sport, Cnn, Soccer, United States, Philadelphia, Fda, Pfizer, West Coast, Vermont, Walter, Southern California, Northeast


Why some senators don't approve of acting FDA head

President Joe Biden is in a standoff with senators in his own party over who should lead the US Food and Drug Administration, a key post in the fight against Covid-19. CNN's Kristen Holmes reports.
Tags: News, Joe Biden, Cnn, Stories, Fda, US Food and Drug Administration, Kristen Holmes


Biden in standoff with Democratic senators over who should lead FDA

Nearly six months into a presidency fully engulfed in a battle against a global pandemic, President Joe Biden is in a standoff with senators in his own party over who should lead the US Food and Drug Administration, a key post in the fight against Covid-19 -- with no indication the White House will name a permanent commissioner anytime soon.
Tags: White House, Joe Biden, Cnn, Fda, Biden, US Food and Drug Administration, COVID


FDA warns of potential rare neurological complication with Johnson & Johnson coronavirus vaccine

The US Food and Drug Administration updated the label on Johnson & Johnson's coronavirus vaccine Monday to warn of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome.
Tags: Cnn, Fda, Johnson, Johnson Johnson, US Food and Drug Administration


The FDA is reportedly planning to warn about a second rare side effect linked to Johnson & Johnson's coronavirus vaccine

A vial of Johnson & Johnson (Janssen's) Covid-19 vaccine. Eduardo Sanz/Europa Press via Getty Images US officials reportedly plan to warn of a rare but serious disorder linked to J&J's coronavirus vaccine. Authorities plan to say that the vaccine is still safe, and that its benefits outweigh the risks. Vaccines from Pfizer-BioNTech and Moderna haven't been linked to the rare side effect, which can cause paralysis, which is usually temporary. See more stories on Insider's bu...
Tags: Washington Post, Cdc, US, Trends, Fda, Pfizer, Johnson, Johnson Johnson, US Food and Drug Administration, J J, Guillain Barre, US Centers for Disease Control and Prevention, Janssen, Moderna, Getty Images Us, Pfizer BioNTech


The FDA issued a warning about a second rare side effect linked to Johnson & Johnson's coronavirus vaccine

A vial of Johnson & Johnson's (Janssen's) COVID-19 vaccine. Eduardo Sanz/Europa Press via Getty Images Federal officials are warning of a rare, serious disorder linked to J&J coronavirus vaccine. Authorities plan to say that the vaccine is still safe, and that its benefits outweigh the risks. Vaccines from Pfizer-BioNTech and Moderna haven't been linked to the rare condition, called Guillain-Barré Syndrome. See more stories on Insider's business page. US health officials at...
Tags: Cdc, US, Trends, Fda, Pfizer, Johnson, Centers For Disease Control And Prevention, Johnson Johnson, US Food and Drug Administration, J J, Guillain Barre, Janssen, Moderna, Pfizer BioNTech, Hilary Brueck Allison DeAngelis, Eduardo Sanz Europa Press


The FDA issued a warning about a rare paralyzing syndrome linked to Johnson & Johnson's coronavirus vaccine

A vial of Johnson & Johnson's (Janssen's) COVID-19 vaccine. Eduardo Sanz/Europa Press via Getty Images Federal officials are warning of a rare, serious disorder linked to J&J coronavirus vaccine. Authorities said that the vaccine is still safe, and that its benefits outweigh the risks. Vaccines from Pfizer-BioNTech and Moderna haven't been linked to the rare condition, called Guillain-Barré syndrome. See more stories on Insider's business page. Officials at the US Food and ...
Tags: Washington Post, Cdc, US, Trends, National Institutes of Health, Fda, Pfizer, Johnson, Centers For Disease Control And Prevention, Johnson Johnson, US Food and Drug Administration, J J, Guillain Barre, Janssen, Moderna, Pfizer BioNTech


The FDA is planning to warn about a second rare side effect linked to Johnson & Johnson's coronavirus vaccine, a report says

A vial of Johnson & Johnson's (Janssen's) COVID-19 vaccine. Eduardo Sanz/Europa Press via Getty Images Officials plan to warn of a rare, serious disorder linked to J&J coronavirus vaccine, a report says. Authorities plan to say that the vaccine is still safe, and that its benefits outweigh the risks. Vaccines from Pfizer-BioNTech and Moderna haven't been linked to the rare side effect. See more stories on Insider's business page. US health officials plan to warn of a rare b...
Tags: Washington Post, Cdc, US, Trends, Fda, Pfizer, Johnson, Johnson Johnson, US Food and Drug Administration, J J, Guillain Barre, US Centers for Disease Control and Prevention, Janssen, Moderna, Pfizer BioNTech, Getty Images Officials


Acting FDA commissioner calls for independent investigation into approval of Alzheimer's drug

US Food and Drug Administration Acting Commissioner Dr. Janet Woodcock on Friday requested an investigation by the US Department of Health and Human Services Office of Inspector General into the controversial approval of the Alzheimer's disease drug Aduhelm.
Tags: Cnn, Fda, US Food and Drug Administration, Janet Woodcock


The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug

Interim FDA Commission Janet Woodcock. Tom Williams/Getty Images Interim FDA Commissioner Janet Woodcock has asked for an outside investigation into an Alzheimer's drug approval. The agency approved the drug, Aduhelm, last month, despite a lack of evidence showing the drug slowed the disease. Officials from Biogen and the FDA worked closely together to revive the drug, raising concerns. See more stories on Insider's business page. The top leader at the US Food and Drug Administra...
Tags: US, Trends, Alzheimer's Disease, New York Times, Healthcare, Fda, US Food and Drug Administration, Biogen, Woodcock, Janet Woodcock, Biden Administration, Dispensed, Allison DeAngelis, Aduhelm, Aduhelm Biogen


Opinion: US Covid response faces doozy of a challenge: Vaccinating kids

Weeks after the US Food and Drug Administration authorized the Pfizer vaccine for adolescents, the United States hit a crucial milestone: More than half of the US population age 12 and older is now fully vaccinated..
Tags: News, US, United States, Stories, US Food and Drug Administration


US Covid-19 response faces doozy of a challenge

Weeks after the US Food and Drug Administration authorized the Pfizer vaccine for adolescents, the United States hit a crucial milestone: More than half of the US population age 12 and older is now fully vaccinated..
Tags: News, US, United States, Stories, US Food and Drug Administration


Opinion: US Covid response faces doozy of a challenge in vaccinating kids

Weeks after the US Food and Drug Administration authorized the Pfizer vaccine for adolescents, the United States hit a crucial milestone: More than half of the US population age 12 and older is now fully vaccinated..
Tags: News, US, United States, Stories, US Food and Drug Administration


Opinion: US Covid-19 response faces doozy of a challenge: Vaccinating kids

Weeks after the US Food and Drug Administration authorized the Pfizer vaccine for adolescents, the United States hit a crucial milestone: More than half of the US population age 12 and older is now fully vaccinated..
Tags: News, US, United States, Stories, US Food and Drug Administration


Alzheimer's and aducanumab: Unjust profits and false hopes

The US Food and Drug Administration's controversial decision to approve aducanumab for the treatment of Alzheimer's disease raises at least three major ethical issues that need to be addressed, states a new article in the Hastings Center Report.
Tags: Science, US Food and Drug Administration


San Francisco becomes first major US city to require COVID-19 vaccinations for city employees

FILE: In this February 2021 photo a sign is displayed at a COVID-19 vaccine site in the Bayview neighborhood of San Francisco. AP Photo/Haven Daley City employees in San Francisco must get vaccinated for COVID-19 or risk losing their jobs. City employees will have 10 weeks after the FDA formally approves the vaccines to get vaccinated. While some companies have announced a similar policy, San Francisco is the first major city to do so. See more stories on Insider's business page. San F...
Tags: New York, Texas, News, Workplace, Cbs News, US, San Francisco, City, Trends, Healthcare, Fda, Vaccine, Morgan Stanley, Los Angeles Times, San Fransisco, City Hall


FDA adds a warning to Covid-19 vaccines about risk of heart inflammation

The US Food and Drug Administration added a warning about the risk of myocarditis and pericarditis to fact sheets for Moderna and Pfizer-BioNTech Covid-19 vaccines Friday.
Tags: News, Stories, Fda, Pfizer, US Food and Drug Administration, Moderna