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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.

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.

Financial Times · 1d

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.

2don MSN

US FDA approves pre-filled version of GSK's shingles vaccine

The U.S. Food and Drug Administration approved a pre-filled syringe version of GSK's blockbuster shingles vaccine Shingrix, ...

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 ...

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 ...

5don 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 ...

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