SILVER SPRING·MAY 08, 2026
Postapproval pregnancy safety studies guidance finalized
FDA issued final guidance on methodologies for postapproval pregnancy safety studies of drugs and biologics.
Latest dispatch MAY 08, 2026
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.
DATELINE HEADLINE AUTH · LEN
SILVER SPRING·APR 30, 2026
Auvelity cleared for agitation in Alzheimer’s dementia
FDA approved Auvelity for agitation associated with dementia due to Alzheimer’s disease, marking its first non-antipsychotic indication.
SILVER SPRING·APR 23, 2026
Gene therapy Otarmeni cleared for genetic hearing loss
FDA approved Otarmeni, a dual AAV vector-based gene therapy, for genetic hearing loss under the National Priority Voucher Program.