The first half of 2025 was a tough time for the Food and Drug Administration (FDA). There were many changes in leadership and layoffs, which made people wonder if the FDA could keep up with its work. The third quarter was no better. The agency had a public disagreement with a company developing gene therapy, one of its top officials resigned and then came back quickly, and it was criticized for rejecting some drugs that treat rare diseases. The FDA had said it wanted to be flexible in evaluating these drugs, so the rejections surprised many. The next few months might bring more tough decisions. Some of these decisions might have to be made during a government shutdown, which would make the FDA’s job even harder. One important decision is about a pill from Novo Nordisk. This pill could be the first alternative to the popular injectable obesity medicines Wegovy and Zepbound. Another decision involves a drug from Biohaven, which could test the FDA’s stance on rare diseases. The FDA might also decide on drugs for a serious kidney condition and a deadly heart disease. In total, BioPharma Dive has added five new decisions to watch to their list, which they update at the start of each quarter.