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Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing ...
London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...
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Zacks.com on MSNGSK Beats on Q2 Earnings & Sales, Stock Gains on '25 Outlook RaiseGSK plc GSK reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), which beat the Zacks ...
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.
The Food and Drug Administration's oncologic drugs advisory committee on voted against approval of GSK's blood cancer drug Blenrep. The British pharmaceutical company said Thursday combinations for ...
GSK is seeking FDA approval for Blenrep—in combination with Takeda's Velcade and dexamethaone—to treat adults with multiple myeloma who've received at least one prior line of therapy.
The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is ...
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Pharmaceutical Technology on MSNGSK’s Blenrep faces setback as FDA cancer committee votes against approvalThe US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk ...
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Zacks Investment Research on MSNFDA Advisory Panel Votes Against Approval of GSK's Blenrep ComboGSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
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