News

pharmaphorum3h
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 Pharma17h
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 ...
Health Care Roundup: Market Talk
Find insight on GSK, Novartis , Sarepta Therapeutics and more in the latest Market Talks covering Health Care.
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.
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 ...
Asianet Newsable on MSN8h
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 ...
BioWorld14h
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.