Accelerated approval gets discussed constantly in the abstract — surrogate endpoints, confirmatory trials, the theoretical risk of a drug reaching market on thinner evidence. A decision earlier this month gives a live, current example of what that pathway actually looks like in practice, end to end. On July 7, 2026, FDA granted accelerated approval to Vera Therapeutics' atacicept-vymj, to be marketed as Trutakna, for reducing proteinuria in adults with primary IgA nephropathy
Five months into FDA's new Quality Management System Regulation, the agency has said out loud what's actually showing up in QMSR Form 483 findings — and it's not a paperwork problem.
FDA just closed one of the more debated gray areas in device submissions — and industry has one week to get ready for the follow-up discussion.
On May 29, FDA finalized its guidance on Human Factors information in device marketing submissions, replacing the 2022 draft.
