FDA Decisions on GSK Drugs

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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

FDA Committee Votes Against GSK Blood Cancer Drug Blenrep

The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.

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.

MedCity News3y

FDA decision for GSK drug opens door to treatment of more cancer ...

The FDA said the GSK drug shrank tumors in 41.6% of patients. Of those responders, 9.1% had a complete response while 32.5% showed a partial response. The median duration of response was 34.7 ...

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 ...

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 ...

MedCity News4y

FDA approves GSK drug for endometrial cancer with specific genetic ...

The FDA approved GlaxoSmithKline drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck's Keytruda as the checkpoint ...

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