Replimune defends its single-arm RP1 melanoma trial data as an FDA advisory panel prepares to vote on whether results are interpretable and RP1 works.
Replimune defended the design and results of its pivotal advanced melanoma trial, arguing to an FDA advisory committee that its oncolytic virus treatment was beneficial …
Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
FDA staff criticized Replimune's RP1 melanoma drug ahead of an advisory meeting, saying its Phase 2 trial failed to prove…
The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier…
Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting
Replimune will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty…
FDA advisory panel backed Replimune's RP1 melanoma data ahead of the agency's August 2 decision despite earlier staff criticism.
STAT is live-blogging a meeting of FDA experts to review Replimune’s experimental melanoma drug, RP1.
Replimune melanoma drug wins support of FDA panel
FDA Staff Unconvinced Drug for Melanoma Shows Benefit
Replimune Skin Cancer Therapy Hopes Revive After Positive FDA Panel Vote - Replimune Group (NASDAQ:REPL)
FDA expert committee votes in favor of Replimune’s melanoma treatment
Replimune Lead Drug Trial Data Deemed 'Not Interpretable' by FDA Staff - Replimune Group (NASDAQ:REPL)
FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data
Tracking the FDA expert review of Replimune’s melanoma treatment
Twice-Rejected Melanoma Drug Gets Surprise Love From FDA Panel
Pharmalittle: We're reading about a Novo setback, support for Replimune's melanoma drug, and more
FDA staff reiterate concerns about Replimune skin cancer treatment
