Q3 2026 Preview: 4 FDA Decisions to Watch

Q3 opens with a concentrated slate of regulatory decisions spanning nephrology, cardiovascular disease, women's health, and infectious diseases. July begins with what could be one of the year's most consequential nephrology approvals as the US Food and Drug Administration (FDA) weighs atacicept for immunoglobulin A nephropathy (IgAN), a decision that could add a novel dual BAFF/APRIL-targeting therapy to the rapidly evolving treatment landscape. Later in the month, regulators will consider MannKind's ReadyFlow Autoinjector for Furoscix, which could significantly simplify outpatient management of edema associated with chronic kidney disease or congestive heart failure by reducing administration time from hours to seconds, before closing July with a decision on a once-weekly lower-estrogen transdermal contraceptive patch designed to expand hormonal birth control options for appropriate candidates.