Drugs

China Surpasses U.S. in Novel Cancer Drug Approvals Since 2023: Analysis

China approved more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDA’s beginning in 2023, according to a new analysis published in Health Affairs Scholar by Friends of Cancer Research. The analysis found that China's National Medical Products Administration (NMPA) approved 94 novel cancer drugs during the six-year period, compared with 87 approvals by the FDA. The NMPA's approval volume increased significantly from 2023 through 2025, exceeding the FDA's output in each of those years.

Despite China's higher overall approval count, the report concluded that the FDA continues to hold important advantages in review speed and innovation, according to the journal article. The agency reviewed oncology drug applications a median of 182 days faster than the NMPA and approved five times as many global first-in-class cancer therapies during the study period. Among the 14 oncology drugs approved by both regulators, FDA authorized the products a median of 164 days earlier than its Chinese counterpart.

"The United States remains a global leader in bringing truly novel cancer therapies to patients," Friends of Cancer Research president Jeff Allen is quoted in a release as saying. However, he warned that China's rapid progress demonstrates that U.S. leadership "cannot be taken for granted," calling for continued investment in regulatory science, predictable development pathways, and research infrastructure.

The study found that expedited regulatory programs played a central role in cancer drug approvals in both countries. Such programs supported 87% of FDA oncology approvals and 65% of approvals by the NMPA, reflecting the growing reliance on mechanisms intended to speed the development and review of therapies for serious diseases.

The authors said the findings underscore the importance of continued regulatory modernization and international collaboration as oncology drug development becomes increasingly global. They argued that understanding the strengths of different regulatory systems can help improve patient access to innovative therapies while maintaining scientific rigor.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome