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pharmaphorum1h
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, ...
GSK Shares Fall After Blood Cancer Drug Likely Headed for U.S. Rejection
The British drugmaker was trying to revive the drug, which was pulled from U.S. markets in 2022 after failing a late-stage ...
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.
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 ...
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.
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 ...