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The FDA has received roughly 4,500 pre-Emergency Use Authorization (EUA) and EUA submissions, and the total volume of submissions received has doubled compared to a year ago. Read More
One arm of the UK’s RECOVERY trial evaluating potential COVID-19 treatments is including aspirin in combination with the drugs being evaluated. Read More
Humanigen on Friday revealed positive interim data in a late-stage clinical trial of its monoclonal antibody lenzilumab for the treatment of COVID-19 patients, but a trial design expert contended that the disclosure was inappropriate and could put the trial’s integrity at risk. Read More
“The diagnostic performance of the test is particularly good in samples with viral loads associated with high risk of viral transmission,” the researchers said. Read More
Regulatory approval “should be based on an independent scientific assessment of the balance of benefits and risks,” the joint statement said. Read More
In an investor call yesterday, Regeneron CEO Leonard Schleifer said he hoped for an early decision by the FDA on an Emergency Use Authorization (EUA) of the company’s COVID-19 antibody cocktail treatment REGN-COV2. Read More
The bitterly fought U.S. presidential battle may drag on for some time if the results are contested, but should Democrat Joe Biden emerge victorious, his administration is expected to take a more hands-off approach to the FDA on COVID-19 vaccines and therapeutics. Read More