New PMC Report Shows FDA Advancing a New Era of Personalized, Patient-Centered Care

Washington, DC, May 14, 2026 (GLOBE NEWSWIRE) -- The Personalized Medicine Coalition released a new report documenting the U.S. Food and Drug Administration’s continued progress in advancing personalized medicine in 2025, including the approval of 16 new personalized medicines representing approximately 36% of all newly approved therapeutic molecular entities. The report also highlights the approval of five new gene- and cell-based therapies and significant advances in diagnostics, artificial intelligence, and rare disease innovation.

The personalized medicine approvals and policy developments at the FDA in 2025 demonstrate that scientific innovation continues to move healthcare away from one-size-fits-all medicine and toward more precise, patient-centered care,” said Gina Ross Murdoch, MBA, president and CEO of PMC. “These advances are helping improve outcomes, expand treatment options, and accelerate the integration of molecular information into clinical decision-making.”

“Fifteen years ago, personalized medicines represented less than 10 percent of new drug approvals. Today, they have become a foundational component of modern healthcare innovation,” said Daryl Pritchard, Senior Vice President, Science Policy at the Personalized Medicine Coalition. “In 2025, personalized medicines accounted for more than one-third of all new drug approvals for the sixth consecutive year, while we also continue to see important advances in gene- and cell-based therapies and steady growth in companion diagnostic approvals and authorizations. Together, these trends reflect more than a decade of sustained scientific progress and demonstrate that personalized medicine is no longer an emerging concept — it is now a central driver of biomedical innovation and patient care.”

The annual report, Personalized Medicine at FDA: The Scope & Significance of Progress in 2025, highlights several milestones underscoring the continued growth and maturation of the personalized medicine field. Among the major 2025 developments:

• FDA approved 16 new personalized medicines, which have now accounted for more than one-third of new therapeutic approvals for each of the past six years.

• FDA approved five new gene- and cell-based therapies for patients with rare genetic diseases and hematologic cancers, including therapies for spinal muscular atrophy, Wiskott-Aldrich syndrome, recessive dystrophic epidermolysis bullosa, and idiopathic macular telangiectasia type 2.

• FDA expedited authorization of the first bespoke CRISPR gene-editing therapy developed for an individual patient with a rare metabolic disorder, signaling the emergence of highly individualized treatment approaches.

• FDA approved or cleared significant new and expanded indications for 16 companion diagnostic testing systems, including new blood-based biomarker tests for Alzheimer’s disease that support earlier and less invasive detection.

• FDA released draft guidance documents establishing frameworks for integrating artificial intelligence into drug development and medical devices and qualified the first AI-based drug development tool under its Drug Development Tool Qualification Program.

• FDA convened Rare Disease Innovation, Science and Exploration workshops to advance regulatory science and individualized therapies for patients with rare diseases.

The report underscores the growing impact of personalized medicine across the healthcare spectrum. While oncology remains a major area of innovation, 2025 advancements also expanded personalized approaches to neurological disorders, rare genetic diseases, immunologic conditions, hematologic cancers, ophthalmology, metabolic disorders, and Alzheimer’s disease. These developments reflect the continued evolution of medicine toward more precise, biomarker-driven, and patient-centered care.

“These newly approved products and regulatory advancements will help innovators and clinicians provide safer, more effective, and more individualized care,” Murdoch said. “But continued progress will require sustained support for policies that encourage scientific innovation and patient access to personalized medicine.”

About the Personalized Medicine Coalition: The Personalized Medicine Coalition (PMC) is a nonprofit education and advocacy organization representing innovators, scientists, patients, providers, and payers. PMC works to advance the understanding and adoption of personalized medicine concepts, services, and products to benefit patients and health systems. PMC will host the 20th Annual Personalized Medicine Conference on November 18–19, 2026, in Boston, bringing together leaders from across the healthcare ecosystem to discuss the future of personalized medicine. For the latest news, research, and conference updates, follow PMC on LinkedIn.

Ancilla Brady
Personalized Medicine Coalition
202-841-3169
abrady@personalizedmedicinecoalition.org

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