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The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S.
The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL patients who are not eligible for autologous stem cell transplant, Roche ...
3M raised its full-year earnings outlook after beating expectations in the second quarter. American Express posted higher revenue in the second quarter, driven by a 20% jump in card fees. The company ...
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used in the proposed dosages for previously treated adult patients with ...
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
The U.S. FDA has approved a prefilled syringe presentation of GSK plc’s SHINGRIX for the prevention of shingles.
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.
Recent developments in the health sector highlight diverse changes from drug pricing initiatives by Bristol Myers and Pfizer ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
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