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GSK, FDA

Medical Dialogues · 1h

GSK fails to gain FDA advisers backing for cancer therapy

GSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of

Bloomberg on MSN · 2d

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.

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.

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 ...

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