RHHBY PDUFA date: FDA decision expected November 30, 2026

The FDA is expected to decide on this application from Roche Holding AG by the PDUFA target action date of November 30, 2026. NDA filing. Extracted from news: FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer,

A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.