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GSK, Food and Drug Administration

The Wall Street Journal on MSN · 2d

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 · 2d

GSK Blood Cancer Drug Blenrep Fails to Win FDA Panel Support

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

Financial Times · 2d

GSK blood cancer drug fails to win backing of key US regulatory panel

GSK has failed to win the backing of influential advisers to the US drugs regulator for a key blood cancer drug, putting its approval in doubt and sending shares in the pharmaceutical group 7 per cent lower on Friday morning.

Fierce Pharma2d

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 ...

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 ...

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 ...

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