Bridget Silverman
Senior Editor
Latest From Bridget Silverman
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
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.
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.
Keeping Track: Breakthroughs Of Summer Break Ground In Psychiatry, Cancer (Especially Nasopharygeal Cancer) And Vaccines
US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.
Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases
FDA wants another trial in ultra-orphan Barth syndrome, but could not identify a feasible design – so Stealth submitted the NDA anyways, based on a retrospective natural history control trial
US Vs EU: First Half 2021 Novel Approval Scorecard
The Pink Sheet's table of the 55 novel products approved in either the US or EU during H1 2021 includes details on approval dates, use of special review pathways and review status such as orphan product or priority review.