Keeping Track: Vascepa Adds CV Risk Reduction Claim And Submissions Pour Into FDA
The latest drug development news and highlights from our US FDA Performance Tracker.
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The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
Brett Giroir’s tenure as acting commissioner of the US FDA won’t last long, but it has marked another high water mark in the pro-innovation climate at the agency, which is an important message about what FDA commissioners do – and don’t – actually do.
US FDA sets 22 April for advisory committee review of obeticholic acid in NASH, though whether the extended review was due to scheduling issues or any questions about Intercept's application itself remain unclear.