News

Pharmaceutical Technology on MSN9d
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.
Fierce Pharma10d
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 staff flags eye safety risks for GSK's blood cancer drug
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...
Fierce Pharma8d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
STAT7d
FDA advisers say risks of GSK blood cancer drug outweigh benefits in surprise setback
FDA advisers on Thursday voted against GSK's blood cancer drug Blenrep, finding that its risks outweighed its benefits at the ...
Medical Dialogues9d
GSK blood cancer drug Blenrep faces USFDA scrutiny over vision issues
GSK's blood cancer drug, Blenrep, is under the U.S. Food and Drug Administration (USFDA) spotlight, as staff reviewers raised ...
BioSpace7d
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 ...
Becker's Hospital Review9d
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 ...
FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting
GSK (GSK) stock in focus as the FDA staff raise safety concerns over Blenrep combo for multiple myeloma ahead of an AdCom ...