If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
Backed by funding from an NIHR Doctoral Award, the guidance is focused on spotting abdominal tumours
BioNTech will supply pumitamig, a PD-L1/VEGF-A bispecific antibody co-developed with Bristol Myers Squibb, while Boehringer Ingelheim will act as the regulatory sponsor of a Phase Ib/II study
Highlights Mirvetuximab-based regimen promise
Backed by a £680,000 grant from Leeds Hospitals Charity, the study is jointly led by academics and clinicians from the University of Leeds and Leeds Teaching Hospitals NHS Trust
Rs 66 lakh acquisition will support DNA engineering and novel cell-gene therapy alternatives to conventional chemotherapy
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