After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.

The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.

The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.

The trend of corporate pruning in med tech continues with Solventum Corp.’s decision to sell its purification and filtration business to Thermo Fisher Scientific Inc. for $4.1 billion. The announcement follows two other big company splits already in 2025: Baxter International Inc.’s separation of its kidney unit as Vantive, bought by Carlyle Group Inc. for $3.8 billion, and Stryker Corp.’s planned sale of its spinal implants business to Viscogliosi Brothers LLC.

Kyorin Pharmaceutical Co. Ltd. struck two licensing deals recently, including one with Hyfe Inc. Feb. 25 to develop the world’s potential first prescription digital therapeutic for chronic cough in Japan.

Researchers from Weill Cornell University filed for protection of discoveries made from investigations into the mechanisms underlying depression, which revealed that a specific brain network is significantly larger in individuals affected by depression.

Citing recent executive orders that suggest additional cuts to the federal workforce may be in the offing, U.S. Sens. Patty Murray, D-Wash., and Jeanne Shaheen, D-N.H., wrote to Health and Human Services Secretary Robert Kennedy urging him to end “indiscriminate cuts that will cause lasting harm to FDA’s public health mission” and to protect the agency’s statutory obligations.

The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.

Roche Holding AG revealed plans to launch its sequencing by expansion technology next year, raising the possibility that rival Illumina Inc. could face a real run for its money. Illumina has long dominated the next-generation sequencing and clinical markets and another – potentially superior – high-throughput system on the horizon could put planned purchases on hold.

In response to the news of reported layoffs at the U.S. FDA over the weekend, Advanced Medical Association president and CEO Scott Whitaker said in press release that these “significant job cuts could have a very negative impact on patient care in this country.”