News

GSK falls as blood cancer drug likely headed for US rejection
GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended ...
FDA votes against overall benefit/risk profile of GSK's multiple myeloma candidate at proposed dosage
Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against ...
GlobalData on MSN1d
GSK’s Blenrep US comeback hindered by eye safety concerns
FDA reviewers have identified high rates of ocular toxicity as GSK looks to place its blood cancer drug back on the market.
GSK's blood cancer drug fails to secure US FDA advisers' support
The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...
Fierce Pharma2d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
MedPage Today on MSN12h
Myeloma Drug's Comeback Nixed by FDA Panel
The comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee ...
The Pharma Letter1d
FDA probes ocular toxicity of Blenrep as GSK seeks new indications
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications.
Fierce Pharma14h
FDA advisors spurn GSK’s Blenrep comeback dreams on safety, trial 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 ...