Bridget Silverman
Senior Editor
Latest From Bridget Silverman
Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach
With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.
Swift Pace Of Accelerated Approval Submissions Suggests Strong Constituency For US FDA Program
FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.
Keeping Track Of US FDA Decisions: COVID-Induced Complete Response Letter For Contepo; Safety Sinks Abicipar Pegol; Approvals For Fintepla and Gimoti
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Pink Sheet Podcast: New Drug Submissions Lag, More US FDA Emergency Use Authorizations On The Way, BsUFA Revenue Misses Estimates
Pink Sheet reporter and editors discuss the lower application submission rate, another EUA for a potential coronavirus treatment, and the biosimilar user fee program missing revenue estimates again.
The End Of The FDA Approvals Boom? Fewer Applications Are A COVID-19 Consequence
Applications for US FDA approval are lower than in recent history, portending a lean 2021.
Keeping Track: Keytruda Claims First TMB-Based Cancer Indication; TG Therapeutics Submits First Umbralisib NDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.