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GSK Falls

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 · 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.

Reuters on MSN · 2d

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.

6don MSN

GSK seeks FDA nod for expanded use of RSV vaccine in adults

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

STAT2d

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 ...

Pulmonology Advisor2d

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.

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