News

BioSpace8h
GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
Applied Clinical Trials Online5h
ODAC Votes Against Risk-Benefit Profile of GSK’s Blenrep Combinations in Relapsed/Refractory Multiple Myeloma
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...
STAT5h
Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
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 ...
BioWorld23h
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 ...
Fierce Pharma1d
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 ...
Devdiscourse2d
Global Health Updates: Profit Raises, Safety Concerns, and Market Moves
This summary highlights significant events in the health sector, including Johnson & Johnson's profit boost from Darzalex, safety concerns for GSK's cancer drug, refugee malnutrition in Gaza, KKR's ...
The Pharma Letter2d
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.