Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Fluad Adjuvant Could Come Under Fire At Advisory Committee
CSL’s (formerly Novartis’) flu vaccine was shown to be non-inferior, but not superior, on immunogenicity endpoints compared to an unadjuvanted vaccine in individuals ages 65 years and older.
Is Fabre-Kramer’s Gepirone Antidepressant Rising From The Dead After 8 Years?
Nothing has been heard about the major depressive disorder treatment since FDA issued a third “not approvable” letter in 2007; advisory committee to discuss NDA in December.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.