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News

GSK, Food and Drug Administration

Digest more
 · 16h · on MSN
GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt
The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work with the FDA.

Continue reading

 · 21h · on MSN
GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug
 · 20h
GSK blood cancer drug fails to win backing of key US regulatory panel
BioSpace
15h
GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
STAT
12h
Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
BioPharma Dive
12h
Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
Fierce Pharma
11h
FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data
The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...

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