In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Bridget Silverman

Senior Editor

Washington, D.C.
Bridget Silverman has been covering FDA for the Pink Sheet since David Kessler was commissioner.  She keeps watch on the drug review process for the FDA Performance Tracker and the Drug Review Profile series. She covered FDA and financial beats as a Pink Sheet reporter before focusing on the drug development and approval process as an editor on Pharmaceutical Approvals Monthly and the NDA Pipeline, developing products that inform our current regulatory tracking features and in-depth FDA review coverage. In her down time, Bridget reads mystery novels and keeps track of her family and three dogs. 

Latest From Bridget Silverman

Orphans Dominate New US FDA Approvals, Thanks To Rethymic, Tavneos, And Livmarli

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.

Drug Review Advisory Committees

Keeping Track: US FDA Is Approving JAK Inhibitors Again, Starting With Incyte’s Opzelura; Seagen’s Tivdak Cleared

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

US FDA Performance Tracker Drug Review

Keeping Track: New Formulations Dominate In CNS; Immunocore Brings First TCR Therapy To US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals
See All
UsernamePublicRestriction

Register