melanoma
2 stories tagged "melanoma"
Drugs & FDA
The FDA Twice Called This Melanoma Trial Uninterpretable. Then It Approved the Drug, at $450,000 a Course.
Federal reviewers rejected Replimune's melanoma therapy twice, faulting a single-arm trial they called not adequate and well-controlled and its results uninterpretable. No new controlled data ever answered them. After a 10-3 advisory vote, the FDA approved it anyway, at $450,000 a course.
CancerSix melanoma patients, six weeks, one common variable: the question oncology is choosing not to study
An oncologist's bedside pattern, a Senate hearing, and a mechanism paper sitting in a mainstream oncology journal: the case that repeated mRNA boosters may be lifting the brakes off cancers oncologists thought they had quiet is no longer fringe enough to wave away.