Gene Therapy Approvals By US FDA Could Double In 2020
CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.
You may also be interested in...
The economic stress on payers caused by the pandemic will cause a setback in the development of payment approaches for regenerative therapy, Blue Cross Blue Shield executive warns.
Priority review is likely in the US for Kite’s second CAR-T therapy offering but it seems the company will have to make do with standard review in the EU.
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.