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

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.