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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Lofexidine Gets US FDA Panel Nod For Mitigating Opioid Withdrawal Symptoms
But Psychopharmacologic Drugs Advisory Committee says US WorldMeds' second proposed indication for facilitating completion of opioid discontinuation treatment is not supported by data from two short-term studies in an 'idealized' population.
US FDA Panel's Achondroplasia Drug Development Advice Delayed By Snow
BioMarin's vosoritide was to be discussed in closed session during advisory committee on drugs for most common form of dwarfism; public session would have addressed general trial design issues, including endpoints, subpopulations and study duration, but inclement weather in the Washington, DC area postponed meeting.
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.