Latest From Bridget Silverman
Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Our interactive table details the novel agents with user fee goal dates before the end of the year.
Looking ahead and looking back, our infographic describes the approval trends at the midpoint in this extraordinary year.
CDER approved a record 27 novel agents between January and June, while a wave of cell therapy and vaccine applications could carry the biologics center to new heights. Merck could close year with four novel approvals.