Posts filtered by tags: Fda[x]


 

The first approved COVID-19 drug is far from 'amazing'

Welcome to Business Insider's daily healthcare newsletter, your daily dose of pharma, biotech, and healthcare news. Subscribe here to get this newsletter in your inbox every weekday. Hollis Johnson/Business Insider Hello, The coronavirus pandemic is overwhelming the US yet again, with the country recording its 2 worst-ever days of infection over the weekend."We are not going to control the pandemic," White House Chief of Staff Mark Meadows said Sunday on CNN.Also in healthcare news: Gile...
Tags: Japan, UK, White House, Germany, US, Trends, Merck, Healthcare, Astrazeneca, Fda, Vaccine, University of Oxford, Donald Trump, Hamburg, Trump, University of Washington


The Barrett Vote: There’s Not a Good Reason for Mike Pence to Preside Over It

Five aides to Vice President Mike Pence, including chief of staff Marc Short, have tested positive for COVID-19. Pence and Short reportedly were in close contact as recently as Friday, but Pence has decided to continue campaigning across the country — and preside over the Supreme Court confirmation vote of Amy Coney Barrett in the U.S. Senate on Monday night — rather than self-quarantine as the CDC recommends.“As vice president, I’m president of the Senate,” Pence said at a rally in Florida on S...
Tags: Florida, News, Supreme Court, Cdc, Senate, White House, Mitch McConnell, Cbs, Fda, Short, Trump, Mike Pence, U S Senate, Democratic Senate, Pence, Schumer


The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease. Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide ...
Tags: Apple, Google, TC, Japan, UK, Indonesia, Australia, White House, China, Russia, US, Tech, Cnn, South Africa, World Health Organization, Astrazeneca


What's the Timeline for FDA Emergency Use Authorization of Coronavirus Vaccines?

A coronavirus vaccine could be available sooner than you might think.
Tags: Fda


Huge COVID study finds remdesivir doesn’t work—FDA grants approval anyway (ars technica)

Enlarge / A vial of Remdesivir during a press conference about the start of a study with severely COVID-19 patients in Hamburg, Germany on April 8, 2020. (credit: Getty | Ulrich Perrey) The US Food and Drug Administration on Thursday issued a full approval of the antiviral drug remdesivir for treating COVID-19—just days after a massive, global study concluded that the drug provides no benefit. “The FDA is committed to expediting the development and availability of COVID-19 treatments during th...
Tags: News, Fda, Beth Mole, US Food and Drug Administration, Hamburg Germany, National Institute of Allergy, Stephen Hahn, Ulrich Perrey


FDA Needs More Safety Data on COVID-19 Vaccines, Experts Say

Title: FDA Needs More Safety Data on COVID-19 Vaccines, Experts SayCategory: Health NewsCreated: 10/23/2020 12:00:00 AMLast Editorial Review: 10/23/2020 12:00:00 AM
Tags: Fda


Mexico will not follow FDA in approving Gilead's COVID-19 drug

Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc's antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said on Friday. Mexico's health regulator Cofepris has already twice denied approval for the drug with a "non-favorable" opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.
Tags: News, Mexico, Fda, U S Food and Drug Administration FDA, Gilead, Hugo Lopez Gatell, Gilead Science Inc, Cofepris


Covid-19 Vaccine Trial From AstraZeneca, Oxford Can Resume in U.S

A late-stage trial of the coronavirus vaccine had been on hold in the U.S. while the FDA reviewed mysterious neurological conditions in...
Tags: Astrazeneca, Fda


Trump quietly closed the U.S.'s vaccine safety office last year. Researchers are scrambling to replace it.

Developers will start rolling out their COVID-19 vaccines in the coming months, leaving U.S. health officials to test their long-term safety. But that won't be easy, especially given that the Trump administration quietly shut down the office responsible for ensuring the safety of vaccines last year, The New York Times reports.Before the late 1980s, vaccine safety relied on parents, doctors, vaccine makers, and hospitals to step forward and report symptoms they feared were connected to a vacc...
Tags: News, Cdc, New York Times, Fda, Times, Centers For Disease Control And Prevention, Trump, Health And Human Services, Lurie, HHS, Alex Azar, Nicole Lurie, National Vaccine Program Office


The best dog food

We compared dozens of products to find the best dog food brands and formulas for all life stages.These dog foods have nutritional profiles and ingredients that are appropriate for the unique needs of different dogs, including puppies, senior dogs, and dogs with food sensitivities.Orijen makes the best dog food you can buy with fresh locally sourced ingredients. Every recipe is packed with protein, limited in carbohydrates, and loaded with natural flavor.Though it may seem like dog food is dog fo...
Tags: Reviews, Usa, Dogs, Pets, US, Trends, Usda, Features, Canada, United States, Buying Guide, New York Times, Fda, Lucy, CANIDAE, DHA


AstraZeneca and Johnson & Johnson get FDA green light to resume coronavirus vaccine trials in the US after participants got sick

Capped vials are being pictured during filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222 VINCENZO PINTO/AFP via Getty Images Two major coronavirus vaccine trials — one from AstraZeneca and the University of Oxford, the other from Johnson & Johnson — will resume coronavirus vaccine trials in the US, the companies announced Friday The late-stage trial had paused September 6 after AstraZeneca reported "suspec...
Tags: Japan, UK, News, Washington Post, US, Trends, United States, Healthcare, Oxford, World Health Organization, Astrazeneca, Fda, Vaccine, University of Oxford, Johnson, Wall Street Journal


AstraZeneca's coronavirus vaccine trial can continue in the US after being halted due to a participant having a 'serious adverse reaction'

Capped vials are being pictured during filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222 VINCENZO PINTO/AFP via Getty Images AstraZeneca and the University of Oxford's coronavirus vaccine trials can continue in the US, The Wall Street Journal reported. The late-stage trial had paused September 6 after AstraZeneca reported "suspected serious adverse reaction" in a UK-based participant. The UK resumed clinic...
Tags: Japan, UK, News, US, Trends, United States, Healthcare, Oxford, World Health Organization, Astrazeneca, Fda, Vaccine, University of Oxford, Wall Street Journal, Johnson Johnson, The Food and Drug Administration


There's Now an FDA-Approved Treatment for COVID-19

The FDA extended its first ever approval (not just an emergency authorization) for a drug to treat COVID-19. The drug is one you’ve probably heard of: the antiviral remdesivir, which has been in use in hospitals for the past few months. Read more...
Tags: Medicine, Fda, Lifehacks, Coronavirus


Costco is selling at-home COVID-19 tests for $129

Costco is now selling COVID-19 tests. REUTERS/Joshua Roberts Costco is selling COVID-19 tests that you can take in the comfort of your own home.  The test uses saliva samples, which buyers mail to a testing center, receiving results in 24 to 48 hours.  The test kit costs $129.99 on Costco.com. Costco is charging an extra $10 for the same kit with video observation and assistance.  Visit Business Insider's homepage for more stories. Costco is selling COVID-19 tests that you can take in the ...
Tags: Trends, Fda, Costco, US Food and Drug Administration, Thermo Fisher Scientific, Kate Taylor, OraSure Technologies, EverlyWell, REUTERS Joshua Roberts Costco, Assay Costco, Blake Dodge Samples, Little Rock Arkansas Dodge


Costco is selling at-home COVID-19 tests for $130

Costco is now selling COVID-19 tests. REUTERS/Joshua Roberts Costco is selling COVID-19 tests that you can take in the comfort of your home.  The test uses saliva samples, which buyers mail to a testing center. They receive results in 24 to 48 hours.  The test kit costs $130 on Costco.com. Costco is charging an extra $10 for the same kit with video observation and assistance.  Visit Business Insider's homepage for more stories. Costco is selling COVID-19 tests that you can take in the comf...
Tags: Trends, Fda, Costco, US Food and Drug Administration, Thermo Fisher Scientific, Kate Taylor, OraSure Technologies, EverlyWell, BLAKE DODGE, REUTERS Joshua Roberts Costco, Assay Costco, Little Rock Arkansas Dodge


Effective Fiber Masks can play vital role in reducing the risk of COVID-19 transmission

Recent FDA chief Dr. Scott Gottlieb argued that he'd "rather try to get everyone in masks" and "try to get them in high-quality masks because we know it's going to slow down the transmission."
Tags: Health, Fda, Scott Gottlieb


Coronavirus Roundup: Trump and Biden Clash Over Pandemic in Last Debate; FDA Approves First Coronavirus Treatment

There's a lot to keep track of. Here’s today’s list of news updates and stories you may have missed.
Tags: Workforce, Fda, Biden, Trump


What it'll take to get a vaccine to Americans

Hollis Johnson/Business Insider Hello,Happy Friday! We here on the healthcare team have had a big week of coronavirus vaccine and treatment developments and preparing for an election that's less than two weeks away.  Let's dive in.But first - want more updates from the healthcare team? Subscribe to this newsletter here — and tell your  friends! A clinical trial volunteer participates in Johnson & Johnson's study to test a coronavirus vaccine candidate Janssen What it'll take to...
Tags: Google, Amazon, New York, US, Trends, Vc, Healthcare, Oscar, Astrazeneca, Fda, Las Vegas, Vaccines, Madison, Alexa, Digital Health, Clover


What’s the Ideal Temperature for Your Refrigerator?

Have you noticed your milk getting frosty? Meat spoiling quickly? It’s likely your refrigerator is set to the wrong temperature. The FDA recommends keeping your refrigerator at or below 40° F (4° C), and your freezer at 0° F (-18° C) to keep your food fresh the longest and prevent the growth of bacteria that could…Read more...
Tags: Kitchen, Food, Food Storage, Fda, Fridge, Lifehacks, Refrigerators, Crowdhacker


Coronavirus live news: Spanish PM says cases closer to 3m; Belgium limits social contacts

Pedro Sanchez stops short of curfew; Belgium bans fans from sports matches; remdesivir approved by FDA for USSurge ‘very serious’ in Germany and ‘out of control’ in SpainBelgium’s deputy PM in intensive care with coronavirusBiden mauls Trump’s record on coronavirus in final presidential debateAustralia: ankle bracelet option for travellers instead of hotel quarantineUK coronavirus updates – live 1.14pm BST Spain’s prime minister, Pedro Sánchez, has said the true number of cases in the countr...
Tags: Science, Germany, Spain, UK News, World news, Australia news, US news, Infectious Diseases, Belgium, Fda, Pfizer, Trump, Bill Melinda Gates Foundation, Pedro Sanchez, CureVac, Tuebingen


We Tried It: Fiix Elbow Tennis Elbow Treatment

There is a lot of cool gear in the golf equipment world that doesn’t always fit neatly into Most Wanted Tests or Buyer’s Guides. You still want to know how it performs. In our We Tried It series, we put gear to the test and let you know if it works as advertised. What We Tried Fiix Elbow, a tennis elbow treatment device that leverages established therapeutic practices in the comfort of your own home. Your Fiix Elbow User Tony Covey – resident jack-of-all-trades (and master of absolutely noth...
Tags: Minneapolis, Sport, Golf, Fda, Tim, Bryson, UEFI, Tony Covey, MyGolfSpy, Tim Tim, Tim He, COVID, Golf Product Reviews, Tim Porth, Nautilus Tim, TaylorMade NDA


Coronavirus live news: Spanish regions demand curfew after national government fails to make decision

Valencia and Castilla and Leon ask for night-time restrictions; remdesivir approved by FDA for US; France extends curfewSurge ‘very serious’ in Germany and ‘out of control’ in SpainBelgium’s deputy PM in intensive care with coronavirusBiden mauls Trump’s record on coronavirus in final presidential debateAustralia: ankle bracelet option for travellers instead of hotel quarantineUK coronavirus updates – live 11.17am BST The Spanish regions of Castilla and Leon and Valencia were clamouring on F...
Tags: Science, France, Germany, US, UK News, World news, Australia news, US news, Infectious Diseases, Malaysia, Fda, Valencia, Leon, Trump, Castilla, Coronavirus


The FDA's panel of experts said its COVID-19 vaccine approval rules aren't strict enough, and could lead to vaccines being rushed out

A volunteer receives an injection from a medical worker. REUTERS/Siphiwe Sibeko The Food and Drug Administration's (FDA) panel of experts questioned the safety standards of the agency's COVID-19 vaccine approval at an advisory meeting Thursday. Independent experts in the FDA's vaccine advisory board said they were concerned about a vaccine being rushed out, and later proving unsafe or ineffective, per Bloomberg. The FDA requires a two-month follow-up after a final vaccine dose before emerg...
Tags: Trends, Bloomberg, Food And Drug Administration, Fda, Pfizer, Donald Trump, Gilead Sciences, Stanford University Medical Center, Siphiwe Sibeko, Diana Zuckerman, National Center for Health Research, COVID, Kate Duffy, Archana Chatterjee, Chicago Medical School, Amanda Cohn


United States: FDA And OSHA Issue Employee Health And Food Safety Checklist For COVID-19 - Husch Blackwell LLP

It is important to note that the checklist is not an OSHA standard that establishes a basis for a fine or liability under the Occupational Safety and Health Act.
Tags: News, United States, Fda, OSHA, Husch Blackwell LLP


Analysis: Election speed read: 11 days to November 3

Breaking -- Remdesivir, a drug President Donald Trump took to help treat his Covid, has gotten FDA approval -- the first such drug to gain access to the US market.
Tags: News, US, Stories, Fda, Donald Trump, COVID


Election speed read: 11 days to November 3

Breaking -- Remdesivir, a drug President Donald Trump took to help treat his Covid, has gotten FDA approval -- the first such drug to gain access to the US market.
Tags: US, Cnn, Fda, Donald Trump, COVID


New test method to standardize immunological evaluation of nucleic acid nanoparticles

Recent successes of several FDA-approved therapeutic nucleic acids, together with the rapid preclinical progression of nucleic acid nanoparticles (NANPs), have made it apparent that immunological effects of NANPs must be carefully assessed to permit their successful clinical translation. Based on extensive studies, a standardized protocol allowing for the assessment of NANPs' pro-inflammatory properties in validated preclinical model, peripheral blood mononuclear cells, has been developed to be ...
Tags: Science, Fda


FDA approves first COVID-19 drug: antiviral remdesivir

It had been authorized for use on an emergency basis since spring.
Tags: Fda


FDA Approves Remdesivir to Treat Hospitalized Covid-19 Patients Despite Mixed Trial Results

The Food and Drug Administration has approved remdesivir to treat hospitalized covid-19 patients. The antiviral drug, which is manufactured and sold by the pharmaceutical company Gilead under the brand name Veklury, is the first to be approved for treating the virus in the U.S.Read more...
Tags: Science, Food And Drug Administration, Fda, Gilead, Coronavirus, Covid 19, Sars Cov 2, Remdesivir