Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
| Topics | Advisory Committee |
Date | Details | Biomedtracker Likelihood Of Approval 1 |
|
AstraZeneca's nirsevimab for prevention of respiratory syncytial virus lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season |
Antimicrobial Drugs |
June 8 (teleconference) |
99% | |
|
Confirmatory study conducted for Eisai's Leqembi (lecanemab) for treatment of early Alzheimer's disease |
Peripheral and Central Nervous System Drugs |
June 9 (teleconference) |
100% | |
|
Strain selection for updated COVID-19 vaccines for the 2023-2024 vaccination campaign |
Vaccines and Related Biological Products |
June 15 (teleconference) |
||
|
Dosage optimization of new drug and biological products for pediatric patients with cancer |
Oncologic Drugs Pediatric Subcommittee |
June 16 (teleconference) |
||
|
Ipsen Biopharmaceuticals' palovarotene capsules for the prevention of heterotopic ossification in adults and children (females ages 8 years and older, males 10 years and older) with fibrodysplasia ossificans progressiva |
Endocrinologic and Metabolic Drugs |
June 28 (teleconference) |
77% | |
|
1 Biomedtracker LOA as of May 26, 2023 |
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