The year 2025 has been a period of intense transition for the pharmaceutical industry. While the FDA faced a “year of upheaval” marked by leadership changes, mass layoffs, and a government shutdown, the industry still managed to bring several life-changing treatments to patients. Although the number of new drug approvals dipped slightly and rejection rates climbed to 15%, the breakthroughs that did cross the finish line are expected to transform modern medicine.
A significant win for public health arrived in June with the approval of Gilead’s Yeztugo. This twice-yearly injection for HIV prevention is being called one of the most important scientific milestones in years. In clinical trials, it was 100% effective at preventing infections, a flawless result that could drastically change the trajectory of the HIV epidemic. Because it only requires two doses a year, it solves many of the “pill fatigue” and adherence issues that come with daily medications, providing a robust new tool even as global funding for HIV programs faces potential cuts.
In the fight against the opioid crisis, the approval of Journavx by Vertex Pharmaceuticals represents a long-awaited shift in pain management. This is the first non-opioid medication for acute pain to be approved in over 20 years. While its $31-per-day price tag has led to some initial pushback from insurers and doctors, the drug is slowly gaining ground. With 300,000 prescriptions already filled, its success depends largely on whether Medicare will begin covering the cost, which would allow it to compete with much cheaper, but more addictive, traditional painkillers.
Cancer treatment also saw a major advancement with the approval of Komzifti, a targeted therapy from Kura Oncology for a specific type of leukemia. This drug is a “menin inhibitor” that helps patients with relapsed or refractory AML, a condition that usually has a very poor outlook. By nearly doubling the remission rate compared to standard chemotherapy, Komzifti has opened the door for more personalized cancer care. Researchers are already looking into using this same technology to treat other cancers, including those that affect children.
Finally, the approval of Voyxact by Otsuka Pharmaceutical has brought new hope to those suffering from rare kidney disease. This drug targets an autoimmune condition that often leads to kidney failure in young adults. By significantly reducing the amount of protein leaking into the urine—a key sign of kidney damage—Voyxact outperformed placebos by a wide margin in clinical trials. As the year draws to a close, these four drugs stand as a reminder that even in a year of regulatory chaos, medical innovation continues to move forward.
Source: Pharma Voice | December 8, 2025
