Spectrum’s Zevalin Still Living In Rituxan’s Shadow, FDA Advertising Letter Shows
This article was originally published in The Pink Sheet Daily
FDA citations of Rituxan comparisons in a promotion for Zevalin throw added salt on old wounds for drug that has taken backseat to Rituxan’s blockbuster story.
You may also be interested in...
FDA advertising enforcement does not preference black-box drugs despite risk-based approach prioritizing products with significant risks; nor are drugs with small patient populations exempt from risk-based approach.
The small oncology company may be able to succeed with the non-Hodgkin lymphoma drug where others have failed.
Pulling the controversial Alzheimer’s drug’s BLA should not exempt Biogen from fulfilling ClinicalTrials.gov reporting requirements for two key studies, even if the research gets terminated, former head of the NIH data repository tells the Pink Sheet.