News

Pharmaceutical Technology on MSN11d
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 Pharma12d
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 Pharma9d
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 ...
STAT9d
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 Dialogues11d
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 Review11d
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 ...