Article Summary:
The FDA’s Center for Devices and Radiological Health (CDRH) released its 2025 annual report, highlighting a record number of 124 novel medical devices authorized last year, including the first blood test to diagnose Alzheimer’s disease. The report also noted that over 250 devices have been approved using real-world evidence.
While a partial government shutdown may affect other federal agencies, the FDA will continue normal operations as it has already been funded for the full year. However, the proposed government spending package does include measures that would impact the FDA, such as enabling the agency to mandate pediatric studies for certain cancer drug combinations and reauthorizing the Pediatric Disease Priority Review Voucher program.
There were some disputes over FDA’s actions, with ImmunityBio claiming the agency had endorsed its cancer drug Anktiva, which the FDA denied. Moderna’s CEO also stated the company would not invest in new late-stage vaccine trials due to opposition from US health officials.
In other news, the Trump administration requested a pause on a lawsuit by Louisiana seeking to restrict abortion pill access, while the launch of the administration’s TrumpRx website for discounted medications was postponed.
The FDA also took regulatory actions, including placing clinical holds on two of Regenxbio’s gene therapy investigational products, approving a multiple myeloma drug combination, and issuing warning letters to several medical product manufacturers for various quality and safety issues.