Spectrum's Apaziquone Pooled Analysis Can't Make Up For Negative Studies
Faced with two unsuccessful pivotal trials, FDA advisory committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been demonstrated.
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Keeping Track: FDA Approves First Rx DHEA, Receives Applications For Midostaurin, Gesulkumab, Biosimilar Avastin
The latest drug development news and highlights from our FDA Performance Tracker.
Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.
Richard Pazdur is moving to a new role in FDA as part of a reorganization driven by the Cancer 'Moonshot.' The most recent Oncologic Drugs Advisory Committee meeting, however, demonstrates that he is still very much in command of cancer drug reviews.