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 | Biomedtracker Likelihood Of Approval 1 |
Research needs for the evaluation of potential adverse health effects in children associated with oral cadmium exposure; cross-cutting regulatory science research activities and the FDA's recent Focus Areas of Regulatory Science report |
Science Board |
Dec. 8 (teleconference) |
||
Cytokinetics' omecamtiv mecarbil to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction |
Cardiovascular and Renal Drugs |
Dec. 13 (teleconference) |
84% |
|
Regeneron Pharmaceuticals' supplemental biologics license application for aflibercept solution for intravitreal injection, submitted in response to FDA’s pediatric written request for studies in the treatment of retinopathy of prematurity |
Dermatologic and Ophthalmic Drugs |
Jan. 9 (teleconference) |
79% | |
Cidara Therapeutics' rezafungin lyophilized powder for injection for treatment of candidemia and invasive candidiasis in adults |
Antimicrobial Drugs |
Jan. 24 (teleconference) |
99% | |
1 Biomedtracker LOA as of Dec. 2, 2022
|