Spectrum’s Zevalin Still Living In Rituxan’s Shadow, FDA Advertising Letter Shows
This article was originally published in The Pink Sheet Daily
Executive Summary
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...
Promotions For Black-Box Drugs Aren’t Specific Enforcement Targets, FDA Says
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.
Cancer Drug Zevalin May Finally Thrive Under Spectrum
The small oncology company may be able to succeed with the non-Hodgkin lymphoma drug where others have failed.
Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.