The FDA is on pace for its lowest tally of new drug and biologic approvals since 2022 while a US federal funding impasse has constrained the agency’s operations. Companies and applicants face delays: new premarket filings that require user fees cannot be accepted, and the agency is absorbing layoffs and slowed reviews. The twin pressures—fewer approvals year‑to‑date and immediate operational limits from the shutdown—are creating a backlog of regulatory actions and extending timelines for sponsors. Biotech firms with pending submissions now face increased regulatory timing risk and potential commercial impact.