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FDA’s LDT rule, CDS guidance combine to complicate regulatory life

Feb. 26, 2025

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.

BioWorld MedTech Regulatory Diagnostics Digital health U.S. FDA Policy

Today's news in brief

BioWorld

BioWorld briefs for Dec. 22, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for Dec. 19, 2025.

In 2025, science’s biggest story was political

BioWorld

In 2025, science saw its breakthroughs, which BioWorld will be covering as part of our end-of-the-year wrap-up. But the biggest science story of 2025 is not about...

Conjugating ferrocene to GPX4 inhibitors to promote ferroptosis

BioWorld Science

Small molecules that induce iron-dependent oxidative cell death known as ferroptosis can be effective against tumors that are resistant to other therapies....

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FDA says yes to Cytokinetics’ aficamten, now Myqorzo, in oHCM

BioWorld

Cytokinetics Inc. scored U.S. FDA marketing clearance Dec. 19 for Myqorzo (aficamten) 5-mg, 10-mg, 15-mg, and 20-mg tablets to improve functional capacity and...