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STAT1h
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 ...
Applied Clinical Trials Online1h
ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
BioSpace4h
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 ...
Fierce Pharma3d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
BioPharma Dive1h
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 ...
Asianet Newsable on MSN13h
GSK’s Blenrep Underwhelms FDA Panel Over Dose Risk-Benefit Balance In Myeloma; Retail Traders Stay Optimistic
The median progression-free survival was 32.6 months on the Blenrep combo compared to 12.5 months on the alternative. While ...
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BioWorld19h
Blenrep misstep? ODAC cites tox, GSK dosing neglect in MM
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory ...