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FDA, GSK and Drug Administration

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.

AOL · 22h

GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

STAT · 1d

FDA advisers say risks of GSK blood cancer drug outweigh benefits in surprise setback

FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the selected dose

TAG24 on MSN1d

Food and Drug Administration may soon revise hormone replacement therapy warnings

US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels ...

FDA eases access to CAR T-cell cancer therapy with updated guidelines

The Food and Drug Administration has announced new guidelines that will make CAR T-cell therapy more accessible to cancer ...

22h

Health Cuts Would Result in Fewer Drugs for Americans, Budget Office Reports

The Trump administration’s proposed cuts to medical research and health agencies will curtail the development of promising ...

USA Today2y

FDA eyes drugs with cancer-causing nitrosamines. What you should know.

U.S. Food and Drug Administration. Add Topic. First it was blood pressure medication. Now FDA eyes more drugs for cancer-causing chemical.

CNN5y

FDA approves new drug for patients with metastatic breast cancer

The US Food and Drug Administration has approved the use of the drug tucatinib, or Tukysa, in combination with chemotherapy, for the treatment of adults with advanced forms of HER2-positive ...

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