The US Food and Drug Administration (FDA) has once again bested the European Medicines Agency (EMA) in terms of new drug approvals in 2025, the latter agency’s Human Medicines in 2025 report reveals.
According to the EMA’s 2025 overview, which was released on 15 January, the regulator recommended 38 novel drugs for approval.
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This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the last week of the year for Omeros’ thrombotic microangiopathy drug, Yartemlea (narsoplimab) and Vanda Pharmaceuticals’ motion sickness therapy, Nereus (tradipitant).
This is despite a tumultuous year for the FDA, which has been fraught with accusations of its politicisation, leadership changes, multiple staff exoduses, mass layoffs and drug review delays.
FDA and EMA approvals down from 2024
While the FDA may have come out on top in terms of overall new drug approvals, the agency’s rate took a small downturn compared to 2024; a year in which it greenlit 50 novel drugs. This was again higher than the number of novel drugs approved by the EMA in the same year.
This could partly be due to the longest-ever US government shutdown in history back in October and November 2025, which lasted 43 days and impacted several of the nation’s health agencies, including the FDA.
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By GlobalDataAccording to GlobalData Life Sciences research analyst Cyrus Fan, despite the upheaval at the FDA in 2025, “a similar number of drugs have been reviewed in the last three years – most of which were reviewed on time”.
Looking forward, Fan warned that disruption at the agency could have a compounding impact, with the reduction in staff potentially having a notable influence on approvals in 2026 compared with 2025.
GlobalData research and analysis manager, Eoin Ryan, added that 2025’s approval turnout could signal a “more challenging regulatory environment for innovative pharmaceutical companies” moving forward.
However, he noted that the EMA’s activity did strengthen towards the end of 2025, with “an uptick in positive recommendations throughout the closing months of the year” potentially signalling renewed momentum as 2026 progresses.
Regulatory rare disease push continues
The FDA also took the win in rare disease approvals, awarding marketing designation to 26 therapies – or 57% of the total approvals for 2025 – in this category, while the EMA handed out 16 across a variety of disease areas. These US approvals come despite a challenging rare disease ecosystem within the country, as federal funding cuts and slackening legislation cause concern for some industry members and patient advocacy groups.
Both agencies are now looking into ways to support companies in the rare disease segment. In September 2025, the FDA debuted The Rare Disease Evidence Principles (RDEP) framework, which was met with lukewarm analyst responses upon its release. In 2023, the EMA updated its PRIority MEdicines (PRIME) scheme, while aiming to address rare disease patient needs through the draft Critical Medicines Act.
Ryan noted medicines that received EMA orphan designation performed well in 2025, as there was a 14% increase in positive opinions on such therapies compared with 2024.
