U.S. FDA Extends Review of Biologics License Application ...
Regeneron announced the FDA extended its review of REGEN-COV for COVID-19 treatment and prophylaxis, setting a new target action date of July 13, 2022. REGEN-COV, not currently authorized in the U.S., is part of Regeneron's efforts to combat COVID-19 with next-generation antibodies, including a first-in-human trial.
Reference News
U.S. FDA Extends Review of Biologics License Application ...
Regeneron announced the FDA extended its review of REGEN-COV for COVID-19 treatment and prophylaxis, setting a new target action date of July 13, 2022. REGEN-COV, not currently authorized in the U.S., is part of Regeneron's efforts to combat COVID-19 with next-generation antibodies, including a first-in-human trial.