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 · 4d

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 · 4d

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.

Medscape17h

FDA Advisory Panel Votes NO on Belantamab for Myeloma

Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...

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 ...

STAT3d

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 ...

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