Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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FDA Panel Rejects Intellipharmaceutics' Opioid For Missing Data, Blue Dye Safety Concern
Panel members question why company pursued filing for its oxycodone ER given lack of data; agrees with FDA that blue Gatorade consumption does not show safety of dye excipient used to deter abuse.
Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel
Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.
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.