PDUFA timelines are still on track

The Covid-19 pandemic hasn't slowed FDA review timelines, as Mizuho points out in a client note. The agency continues to churn out NDA and BLA reviews on time, or even ahead of PDUFA deadline.

Mizuho has compiled a list of companies, and their respective drugs up for approval, in a handy document here. 

“We believe this is encouraging in light of Covid-19,” the Japanese banking firm said. “While companies may be impacted from a commercial and clinical development standpoint to various degrees, there appears to be minimal impact on regulatory review timelines.”