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GSK, Food and Drug Administration

The Wall Street Journal on MSN · 1d

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 · 1d

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 · 1d

GSK's blood cancer drug fails to secure US FDA advisers' support

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending the British drugmaker's U.

Fierce Pharma1d

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 ...

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 ...

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 ...

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