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News

GSK, Food and Drug Administration

Digest more
 · 1d · 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

 · 2d · on MSN
GSK's blood cancer drug fails to secure US FDA advisers' support
 · 1d
GSK blood cancer drug fails to win backing of key US regulatory panel
Fierce Pharma
2d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
STAT
1d
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 ...
BioSpace
1d
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 Pharma
4d
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 ...

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