"GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple ...

The British pharmaceutical company said combinations for its Blenrep drug were evaluated in adults with relapsed or ...

The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory ...

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...

On a quest to bring its multiple myeloma antibody-drug conjugate (ADC) Blenrep back to the U.S. | Members of the FDA's Oncologic Drugs Advisory Committee voiced concerns with ocular toxicity side ...

The FDA has approved a prefilled syringe option of Shingrix which will streamline administration of GSK’s herpes zoster ...

The Food and Drug Administration (FDA) has approved a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted). Shingrix is indicated for the preven ...

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

GSK Plc’s blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

George Mulligan, PhD, previews the FDA's ODAC meeting discussing the application of belantamab mafodotin-based combinations for the treatment of multiple myeloma.

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...

The FDA has approved Benlysta in an autoinjector that can be used at home to treat lupus nephritis, a kidney complication, in children.