Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
After 40 Years, Is Vaccine For Group B Strep On Horizon?
US FDA advisory committee debates possible endpoints to demonstrate vaccine effectiveness in maternal immunization; Pfizer, which has candidate in Phase I/II study, says use of surrogate endpoint of protection may be most feasible.
Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role
Main concerns involved the delayed onset to meaningful pain relief and the safety signal of hypoxia.
Bluebird Expects Three Filings In 2020, But US Zynteglo Submission Pushed Back
A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: