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Evusheld’s EUA was supported by data from a phase 3 study, which showed the combination reduced the risk of developing symptomatic COVID-19 by 77 percent vs. placebo. Read More
The FDA has revised Pfizer/BioNTech’s Emergency Use Authorization (EUA), allowing a booster of the companies’ COVID-19 vaccine in teenagers aged 16 and 17 six months following completion of a primary vaccination series. Read More
An FDA advisory committee unanimously rejected recommending approval of Reata Pharmaceuticals’ bardoxolone methyl as a treatment for patients 12 years and up with chronic kidney disease caused by Alport syndrome (AS), a rare genetic disorder. Read More
The WHO said the evidence was less certain for severe and critically ill COVID-19 patients and suggested trials continue for this subgroup to gather more data. Read More
In a 13-10 vote yesterday, an FDA advisory committee recommended that the FDA should grant Emergency Use Authorization (EUA) for molnupiravir, the antiviral pill co-developed by Merck and Ridgeback Biotherapeutics. Read More
Merck’s COVID-19 antiviral, molnupiravir, lowered the risk of hospitalization or death by just 30 percent, according to the results of a late-stage study that will be reviewed today by an FDA expert panel. Read More