RSV Vaccines Need Multiple Animal Models Before Infant Testing, Panel Says
US FDA's advisors want data from three animal models – not just the cotton rats that Janssen was hoping for – before candidate vaccines are tested in healthy infants.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Sponsors have been increasingly developing vaccine candidates for the respiratory syncytial virus with an unmet need existing for infants; the advisory committee will evaluate FDA's proposed approach for developing candidates in the target population.
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.