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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Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents
US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.
RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns
Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.
ASCO - Servier’s Vorasidenib Puts The Brakes On Brain Cancer In INDIGO
Servier’s targeted therapy, vorasidenib, can effectively delay the need for more drastic treatment in patients with low-grade glioma, but increases in liver enzymes including two cases of Hy’s law have cast some shade over the INDIGO data.