In 2025, the Food and Drug Administration (FDA) approved 46 new medicines. This is fewer than the previous two years but still more than usual. This news brings some comfort to the pharmaceutical industry, which faced many unexpected changes in regulations throughout the year. Under Commissioner Marty Makary, the FDA has been working to make drug development and evaluation processes more efficient. However, frequent changes in key positions and significant job cuts have created uncertainty for drug developers and delayed some product reviews, according to analysts at RBC Capital Markets. They noted that ongoing leadership changes and unpredictability could pose challenges for the industry. To keep the biotech sector growing, it’s crucial for the FDA to manage evaluations well and maintain clear communication with drugmakers. BioPharma Dive has highlighted five important decisions to watch in the next three months, including two drugs that received special vouchers to speed up their reviews. We’ll update this list at the beginning of each quarter.