The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer widens the opportunities for patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents.

CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with SYS-6040 for advanced solid tumors.

The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.

The unrelenting pressure on medical practice in the U.S. has sparked some innovations, but a legislative innovation is now in the works that would fundamentally shift how at least some drugs are prescribed. The Healthy Technology Act of 2025 (H.R. 238) would allow AI and machine learning algorithms to write prescriptions for pharmaceuticals, although the lack of co-sponsors for H.R. 238 suggests that this bill is not ready for prime time just yet.

The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.

The U.S. FDA has posted several class I recalls in recent days, including a removal of one model of the Medtronic Vascular’s Pipeline Vantage embolization device due to insufficient apposition to the vessel wall.

The U.S. FDA warning letter to Q’Apel Medical Inc., of Fremont, Calif., lists several deviations from the regulation, but the agency said the company’s Hippo device for is misbranded because Q’Apel had failed to file with the agency for changes to the device design.

Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.