Regeneron's bid for COVID-19 drug's full approval hits snag as FDA extends review

Regeneron's bid for COVID-19 drug's full approval hits snag as FDA extends review

Source: 
Fierce Pharma
snippet: 

Just as Regeneron’s COVID-19 antibody combination, REGEN-COV, is sidelined in the U.S. thanks to omicron, the drug has hit a hiccup on its quest for a full FDA nod.

The FDA has extended the review of REGEN-COV by three months to July 13, Regeneron said Thursday. The agency wants to take the time to review additional data on how well the therapy could prevent COVID before exposure to the SARS-CoV-2 virus, the company said.