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The Food and Drug Administration late Friday expanded its emergency use authorization for Gilead Sciences ’ Covid-19 therapeutic remdesivir, saying the drug can now be used in any patient hospitalized for Covid-19. The agency previously had authorized the unapproved treatment for only the sickest Covid-19 patients. The FDA said it now believes that the drug “may be effective” in all hospitalized Covid-19 patients, and that the potential benefits outweigh the known and potential risks. (Nathan-Kazis, 8/29)

The approval allows doctors freedom to prescribe the antiviral earlier. But it comes less than a week after the agency approved use of convalescent plasma without published scientific support, fueling concerns the agency is yielding to political pressure."It seems to be a pattern of approval without science, without data, without evidence," said Dr. Eric Topol, vice president for research at Scripps Research in La Jolla, California and a national expert on the use of data in medical research. (Weintraub, 8/28)

The FDA said in a press release that it would expand the emergency use authorization of the drug to allow it to be used for “treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.” (Axelrod, 8/28)

In the hunt for COVID-19 drugs, Gilead Sciences' remdesivir remains the sole pharma product authorized in the U.S. But it's reserved for hospitalized patients, leaving those with mild or moderate disease in the lurch. A research team out of Texas is looking to change that. It's using its thin film freezing technology to create a powdered formulation for use in an inhaler. The approach could vastly expand patient access to the drug—if the California-based biopharma bites. (Kansteiner, 8/28)