The FDA accepts GSK's BLA seeking approval of Blenrep combinations for treating relapsed/refractory multiple myeloma. A decision is due on July 23, 2025.

Pharma titan GSK has announced that US regulators have accepted for review Blenrep combinations for the treatment of relapsed ...

The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License ...

GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...

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Intellia Therapeutics received the FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for nexiguran ziclumeran ...

US FDA accepts for review GSK’s Blenrep combinations for the treatment of relapsed/refractory multiple myeloma: London, UK Tuesday, November 26, 2024, 09:00 Hrs [IST] GSK plc an ...

GSK PLC said on Monday that the US Food & Drug Administration accepted a biologics license application for its Blenrep combinations for the treatment of relapsed and refractory multiple myeloma, both ...

GSK's drive to resurrect its multiple myeloma therapy Blenrep has continued with new data from the DREAMM-7 trial showing an increase in overall survival (OS) with the drug had reached statistical ...

GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug ...

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