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GSK falls

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.

Bloomberg on MSN · 20h

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

Reuters on MSN · 19h

GSK falls as blood cancer drug likely headed for US rejection

GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended against approving its blood cancer drug Blenrep, citing earlier concerns over side effects.

STAT12h

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 ...

BioSpace15h

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 ...

Infectious Disease Advisor14h

FDA to Review Arexvy for 18 to 49-Year-Olds at Increased RSV Disease Risk

The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

21h

FDA rejects overall benefit/risk profile of GSK's blood cancer drug dosage

Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...

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