Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short
Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.
You may also be interested in...
CD47 was once seen as one of the hottest properties in immunotherapy, but multiple setbacks have tempered enthusiasm for targeting the ‘don’t eat me’ cell surface protein. I-Mab and Gilead are just two casualties.
The Bologna-based firm is looking to grow its presence in the US as well as in gastrointestinal and liver disease as it acquires Intercept, which received a second rejection for its NASH drug OCA in June.
Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.