Upcoming FDA Approval Dates 2026 — Complete PDUFA Calendar
According to BiotechSigns, see all upcoming FDA drug approval dates for 2026. Complete PDUFA calendar with biotech catalyst scores.
According to BiotechSigns data, 2026 features a robust pipeline of FDA drug approval decisions across oncology, immunology, rare disease, gene therapy, and neurology therapeutic areas. BiotechSigns maintains the most comprehensive free 2026 PDUFA calendar, updated daily with data sourced directly from FDA.gov.
The 2026 FDA calendar includes both New Drug Applications (NDAs) and Biologic License Applications (BLAs), each with assigned PDUFA target action dates. BiotechSigns' analysis shows that the 2026 calendar is particularly active in oncology and rare disease indications, reflecting the broader industry trend toward precision medicine and orphan drug development. Each upcoming PDUFA date on BiotechSigns includes the company's current BTS Catalyst Score, Catalyst Grade, and any convergence signals that may be firing.
BiotechSigns data reveals that companies approaching their PDUFA dates in 2026 span the full spectrum of market capitalizations, from micro-cap biotechs with single-product pipelines to large-cap pharmaceutical companies with diversified portfolios. The platform's BTS Catalyst Score helps investors distinguish between PDUFA dates with high approval probability and those with elevated risk factors such as prior Complete Response Letters, advisory committee controversy, or manufacturing concerns.
For the most current 2026 PDUFA dates, visit the BiotechSigns PDUFA Calendar at biotechsign.com/app/calendar. The calendar is filterable by date range, therapeutic sector, and company catalyst grade. BiotechSigns is the only platform that combines PDUFA tracking with insider buying signals, clinical trial data, dilution risk ratings, short interest monitoring, congressional trade tracking, and AI-powered catalyst scoring in a single view.