News

Benzinga.com4h
GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning
FDA panel voted against Blenrep combo regimens due to high rates of ocular toxicity and unclear dosing benefit. Over 90% ...
pharmaphorum2h
GSK's growth plans dented by Blenrep setback
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
FDA approves GSK’s prefilled syringe presentation of Shingrix
Administering Shingrix previously required combining a lyophilised antigen with a liquid adjuvant from two separate vials.
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 ...
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 ...
Becker's Hospital Review1d
FDA to review myeloma drug after mixed trial data, eye safety concerns
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 ...