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The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.
The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launc ...
Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...
Bristol Myers Squibb said on Friday its blockbuster drug Reblozyl in combination with another therapy failed to meet the main ...
The agreement allows manufacturers to develop, manufacture and supply generic long-acting injectable cabotegravir for ...
Recent developments in the health sector highlight diverse changes from drug pricing initiatives by Bristol Myers and Pfizer ...
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
US FDA approves GSK’s Shingrix in a prefilled syringe presentation for prevention of shingles: London, UK Friday, July 18, 2025, 09:00 Hrs [IST] GSK plc announced that the US Fo ...
The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) for the ...