SILVER SPRING·MAY 08, 2026
Bizengri cleared for NRG1 fusion-positive cholangiocarcinoma
FDA approved Bizengri (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma under the National Priority Voucher Pilot Program.
FDA issued final guidance on methodologies for postapproval pregnancy safety studies of drugs and biologics.
FDA approved Bizengri (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma under the National Priority Voucher Pilot Program.
FDA approved Auvelity for agitation associated with dementia due to Alzheimer’s disease, marking its first non-antipsychotic indication.
FDA approved Otarmeni, a dual AAV vector-based gene therapy, for genetic hearing loss under the National Priority Voucher Program.