Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
| Topics | Advisory Committee |
Date | Details |
|
Reata Pharmaceuticals' bardoxolone methyl capsules to slow the progression of chronic kidney disease caused by Alport syndrome in patients 12 years of age and older |
Cardiovascular and Renal Drugs |
Dec. 8 (teleconference) |
(Also see "Reata’s Bardoxolone Shot Down, But US FDA Advisors Offer Suggestions For Improved Study" - Pink Sheet, 8 Dec, 2021.) |
|
Innovent Biologics (Suzhou) Co., Ltd.'s sintilimab injection for use in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with Stage IIIB, IIIC or IV non-squamous non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations |
Oncologic Drugs |
Feb. 10 (teleconference) |