Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keeping Track: New Claims For Tukysa, Brukinsa; US FDA Wants More Patients To Support Donanemab, Pediatric Airsupra Bids
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022
Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
Keeping Track: A Blizzard Of Submissions At The US FDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals
Pink Sheet infographic details the 20 complete response letters the US FDA issued for novel agents last year.