News

Fierce Pharma9d
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 ...
Fierce Pharma7d
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 ...
Healio6d
‘Surprising’ setback: ODAC rebuffs Blenrep for multiple myeloma, citing ocular toxicity
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...
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.
CURE6d
FDA Votes Against Proposed Blenrep Treatment Combo’s for Multiple Myeloma
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
FDA staff raises eye damage concerns 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 ...
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 ...
Becker's Hospital Review8d
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 ...