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GSK, Food and Drug Administration

The Wall Street Journal on MSN · 17h

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 · 23h

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.

Financial Times · 21h

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.

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 ...

11hon MSN

BofA Maintains a Sell Rating on GSK plc (GSK), Sets a PT of p1,510

The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are ...

Fierce Pharma12h

FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...

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