melanoma
4 stories tagged "melanoma"
The Last Time Moderna's Stock Soared on Vaccine News, Insiders Sold $400 Million. It's Happening Again.
Moderna's stock has run up 137 percent in a month on a melanoma-vaccine trial that has not released its detailed data or reported overall survival. As retail chased the rally, the CEO sold $28.7 million in shares two weeks before the readout, and the rest of the C-suite cashed out after the stock tr
Drugs & FDAThe FDA's Reviewers Called This Melanoma Data 'Not Interpretable.' Nine Days Later, the Agency Approved the Drug.
Twice the FDA rejected Replimune's engineered-herpes melanoma therapy, its reviewers calling the single-arm trial not interpretable. The design never changed. A 10-3 advisory vote came anyway, and nine days after that memo, the accelerated approval.
Drugs & FDAThe 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.