Bridget Silverman
Senior Editor
Latest From Bridget Silverman
Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials
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.
Keeping Track: US FDA Clears Vaxneuvance, Rezurock And Karendia, But Not Teplizumab
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Lineup Of US FDA’s Potential Novel Approvals In H2 2021
Our interactive table details the novel agents with user fee goal dates before the end of the year.
2021 Approvals By The Numbers
Looking ahead and looking back, our infographic describes the approval trends at the midpoint in this extraordinary year.
US FDA’s Novel Approval Count Hits 32 In First Half Of 2021, With More Than 40 Goal Dates Ahead
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.