Bridget Silverman
Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
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.
With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.