News

pharmaphorum46m
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, ...
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 ...
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.
NDTV Profit9h
GSK Blood Cancer Drug Blenrep Fails To Win FDA Panel Support
GSK remains confident in Blenrep’s safety and efficacy, and will work with the FDA as it reviews the drug, the company said ...
Asianet Newsable on MSN5h
GSK’s Blenrep Underwhelms FDA Panel Over Dose Risk-Benefit Balance In Myeloma; Retail Traders Stay Optimistic
The median progression-free survival was 32.6 months on the Blenrep combo compared to 12.5 months on the alternative. While ...
BioWorld12h
Blenrep misstep? ODAC cites tox, GSK dosing neglect in MM
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 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 ...