Keeping Track: Year-End Submissions Rush Brings Seven Novel Agents To US FDA

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.