In 2025, the FDA approved 46 new drugs, slightly decreasing the five-year average to 48. However, this number remains higher than the historical average of 36 new drugs each year since 1993. Cancer drugs led the approvals, making up 35% of the new treatments, a notable increase from the previous five-year average of 29%. The other prominent areas for new drugs included cardiology, with 11%, and allergies/inflammatory diseases at 9%.
Among these approvals, kinase inhibitors stood out. Novartis’s remibrutinib became the 100th kinase inhibitor approved, illustrating the growing versatility of these drugs beyond cancer treatment. Philip Cohen from the University of Dundee emphasized that this field is still evolving.
Despite staffing changes and policy updates at the FDA following political events, the organization introduced new programs aimed at expediting drug approvals. For instance, the FDA Commissioner’s National Priority Voucher (CNPV) program seeks to reduce review times from 10-12 months to just 2 months. However, concerns have been raised about whether this might compromise safety standards.
The average peak sales for newly approved drugs sit at around $1.2 billion, according to a Boston Consulting Group analysis. Yet 2025 was a tumultuous year for the FDA, with over 18% of employees leaving in the first nine months. This upheaval included five different directors in the Center for Drug Evaluation and Research.
In non-cancer related approvals, Insmed introduced brensocatib, the first DPP1 inhibitor for bronchiectasis, a chronic lung disease affecting hundreds of thousands in the U.S. This marks a breakthrough in treating what was previously a largely unaddressed condition. The drug is expected to generate around $6.3 billion in peak sales if further indications are approved.
New pain management options also emerged. Vertex’s suzetrigine aims to provide a non-addictive solution for acute pain. While it shows promise, its success against existing pain medications remains to be seen, especially since it has a higher price tag than generics.
GSK and Innoviva Specialty Therapeutics each launched novel antibiotics. GSK’s gepotidacin offers a new oral option for treating uncomplicated urinary tract infections. Meanwhile, Innoviva’s zoliflodacin targets gonorrhea, with its development coordinated by a non-profit organization, aiming to ensure global access.
This year also spotlighted advancements in gene therapy. The approval of etuvetidigene autotemcel for Wiskott–Aldrich syndrome by a non-profit organization marks a significant achievement. The uniqueness of this therapy lies in its method of restoring platelet function by genetically modifying a patient’s own stem cells.
As the industry progresses, the emphasis on patient-centered treatments highlights a shift in focus. Consumers are increasingly involved in the development process, advocating for transparency, affordability, and accessibility of new drugs.
For more detailed statistics on these approvals and their implications, you can check out the official FDA resources [here](https://www.fda.gov).
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Biomedicine,general,Pharmacology/Toxicology,Biotechnology,Medicinal Chemistry,Molecular Medicine,Cancer Research
