GSK Adds EU to Blenrep Checklist as FDA Sets New PDUFA Date

GSK adds EU to Blenrep checklist as FDA sets new PDUFA date

GSK adds EU to Blenrep checklist as FDA sets new PDUFA date Jonah.Comstock Thu, 24/07/2025 - 18:07 Bookmark this

FDA Extends Review of Blenrep Combinations in Multiple Myeloma

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.

FDA delays review date for a return to market for GSK's Blenrep

The FDA on Wednesday extended its review of GSK’s multiple myeloma drug Blenrep by three months as the company seeks a relaunch after it was pulled from the US almost three years ago. The agency' ...