The FDA authorized the use of an experimental antibody treatment for Covid-19

The FDA authorized the use of an experimental antibody treatment for Covid-19

Amid record levels of new Covid-19 infections and hospitalizations, the Food and Drug Administration announced on Saturday that this would allow emergency use drug therapy called an antibody RAIN-COV2 which helps the immune system fight the virus. The treatment, developed by biotech company Regeneron, consists of two antibodies called casirivimab and imdevimab which have so … Read more

FDA chief walks back key claim about convalescent plasma for Covid-19

Why experts are worried about the FDA’s approval of convalescent plasma for Covid-19

The Food and Drug Administration whipped up a fierce controversy Sunday when it decided to grant an Emergency Use Authorization, or EUA, for convalescent plasma to be used as a treatment for Covid-19. And by Monday night, FDA commissioner Stephen Hahn admitted on Twitter he had overstated the effectiveness of the treatment. I have been … Read more

Trump blames FDA ‘deep state’ for slowing COVID-19 vaccine trials

Trump blames FDA ‘deep state’ for slowing COVID-19 vaccine trials

WASHINGTON — U.S. President Donald Trump on Saturday accused members of the “deep state” at the Food and Drug Administration, without providing evidence, of working to slow testing of COVID-19 vaccines until after the November presidential election. In a Twitter post, Trump said the deep state “or whoever” at the FDA was making it very … Read more

Yale’s COVID-19 saliva test used in NBA gets FDA OK for emergencies

Mudslide in Arctic Norway sweeps houses into the sea

The U.S. Food and Drug Administration on Saturday granted emergency use authorization to Yale School of Public Health’s saliva test to detect COVID-19, after a trial on National Basketball Association players and staff. SalivaDirect, the fifth saliva test approved by the FDA for the disease, requires no swab or collection device and uses spit from … Read more

Former FDA Commissioner on Russia COVID Vaccine: ‘I Wouldn’t Take It’

Former FDA Commissioner on Russia COVID Vaccine: ‘I Wouldn’t Take It’

A scientist prepares samples during the research and development of a vaccine for the coronavirus at a laboratory of BIOCAD biotechnology company in Saint Petersburg, Russia June 11, 2020. (Anton Vaganov/Reuters) Former Food and Drug Administration commissioner Scott Gottlieb sounded a note of caution on Tuesday against Russia’s claim to have produced a vaccine for … Read more

U.S. FDA revokes emergency use status of drug touted by Trump for COVID-19

U.S. doctors group sues FDA for limiting access to COVID-19 drug hydroxychloroquine

The U.S. Food and Drug Administration on Monday revoked the emergency use authorization for malaria drug hydroxychloroquine as a treatment for COVID-19, the use of which has been championed by U.S. President Donald Trump. The FDA said based on new evidence, it was no longer reasonable to believe that oral formulations of hydroxychloroquine and the … Read more

U.S. doctors group sues FDA for limiting access to COVID-19 drug hydroxychloroquine

U.S. doctors group sues FDA for limiting access to COVID-19 drug hydroxychloroquine

A group of conservative U.S. physicians has sued the Food and Drug Administration for restricting the use of the malaria drug hydroxychloroquine for COVID-19, arguing that the therapy should be made widely available to fight the pandemic. The lawsuit represents the latest front in a highly politicized American debate about access to hydroxychloroquine. President Donald … Read more

The FDA just gave the green light to a new kit that allows you to swab for coronavirus at home

The FDA just gave the green light to a new kit that allows you to swab for coronavirus at home

The Food and Drug Administration granted “permission for emergency use“Towards a new coronavirus test kit on Saturday that will allow people to send self-collected nasal samples to laboratories by mail. The new test, by Everlywell Inc, is the third sample collection kit at home, with special accelerated approval from the FDA under an emergency authorization … Read more

U.S. CDC, FDA chiefs in self-quarantine following COVID-19 exposure: Report

U.S. CDC, FDA chiefs in self-quarantine following COVID-19 exposure: Report

Two U.S. cabinet-level officials were self-quarantined on Saturday after coming into contact with someone who tested positive for COVID-19, according to a spokesperson and a press release. Centers for Disease Control and Prevention Director Robert Redfield “will telework over the next two weeks” following a “low-risk exposure” on Wednesday to a person in the White … Read more

U.S. FDA authorizes first at-home saliva test for COVID-19

U.S. FDA authorizes first at-home saliva test for COVID-19

The U.S. Food and Drug Administration said on Friday that it approved the first diagnostic test for the new coronavirus that allows patients to collect saliva samples at home. The decision is part of the FDA’s efforts to expand testing capabilities for the rapidly spreading virus, which has caused more than 70,000 deaths in the … Read more