"It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the USA that is available for all appropriate patients in need".
"This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19", says Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center who was among the first to treat patients from the Diamond Princess Cruise ship with remdesivir and runs one of the drug's clinical trials.
The drug, developed by Gilead Sciences, received emergency use authorization from the FDA in May, which allowed hospitals and doctors to administer the drug to hospitalized COVID-19 patients.
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The US Food and Drug Administration (FDA) said Veklury, the drug's brand name, cut the recovery time on average by five days during clinical trials. That study has not been reviewed by outside experts.
Gilead has questioned the potential for bias in the World Health Organization study, which was not "blinded", meaning that participants and their doctors were aware of which treatments were being used. Shares of Gilead rose 4.3% in after hours trading to $63.30.
Dexamethasone, a low-priced steroid now widely used on Covid patients in intensive care in the United Kingdom, was not included in this study. The drug also has not been proven to significantly help moderately-ill patients, and many doctors remain wary of using it in patients with less severe illness.
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The former New York City mayor called police after that encounter, but there is no indication an investigation was launched. Cernovich added, defending Giuliani from claims that he knowingly got into bed with a purported child.
The other two studies, sponsored by Gilead, did not include placebo controls, but compared patients receiving the drug and standard of care to those getting standard of care alone.
In August, the company said it planned to produce more than 2 million treatment courses of remdesivir by the end of the year and anticipated being able to make "several million more" in 2021, adding it has increased the supply of the drug more than fiftyfold since January.
The drug is either approved or has temporary authorisation in about 50 countries, he noted.
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Gilead said it is still working to understand the full potential of remdesivir, in different settings and as part of combination therapy approaches. The drug is now administered intravenously, but the company is working on developing an inhaled version.