Regeneron obtains FDA emergency use authorization for its COVID-19 antibody treatment

397
SHARE

On the other hand, Regeneron president and chief executive officer Dr. Leonard Schleife said the FDA’s EUA is “an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection.”

Pfizer and BioNTech submit EUA application with the FDA

Meanwhile, Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) submitted a EUA application with the FDA for their mRNA-based COVID-19 vaccine, which is 95% effective in preventing the virus infection.

In a video shared on Friday, Pfizer CEO Dr. Albert Bourla said, “It is with great pride and joy and even a little relief that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the FDA’s hands. This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day,”

“We have operated at an extraordinary speed in our clinical development program, from concept to regulatory filing, while always maintaining our focus on safety,” he added.