FDA Puts Regeneron/Roche COVID Therapy on Hold for 3 Months

Published on April 14, 2022

The FDA is hitting pause on its review of Regeneron Pharmaceuticals Inc’s COVID-19 antibody therapy application. It’s like when a teacher wants to take more time looking over your homework before giving it a grade. The FDA wants to make sure all the i’s are dotted and t’s are crossed, so they’re extending their review by three whole months! While this may delay the approval process, it’s ultimately in the best interest of ensuring the safety and efficacy of the therapy. In the meantime, researchers and scientists will continue to gather more data on the antibody therapy’s effectiveness in treating COVID-19. This delay could also mean that the FDA is being extra cautious due to emerging variants and wanting to evaluate any potential implications they might have on the treatment. If you want to stay up-to-date with the latest research and developments related to this therapy, keep an eye on further updates from Regeneron and Roche as well as the FDA.

The U.S. Food and Drug Administration has extended by three months its review of Regeneron Pharmaceuticals Inc’s application for the full approval of its COVID-19 antibody therapy, the U.S. drugmaker said on Thursday. Before making its decision, the health agency wants to…

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